DSM Biomedical, Inc.
Exton, PA, US
DSM Biomedical, Inc. appears in FDA device records in Exton, PA. FDA records list 54 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 31 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to DSM Biomedical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Kensey Nash Corporation510(k), recall
- Orthovita, Inc.510(k), recall
- Orthovita, Inc., dBA Stryker Orthobiologics.enforcement report, recall
- Stryker Orthobiologics, Inc.enforcement report, recall
510(k) clearance history
Showing 50 of 54FDA records hold 54 510(k) clearances for DSM Biomedical, Inc. between 1993 and 2023. The busiest year on record is 2003, with 6. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1995 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2003 | 6 |
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 6 |
| 2007 | 5 |
| 2008 | 4 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230054 | DSM Biomedical Calcium Phosphate Cement | MQV | Substantially Equivalent | |
| K193212 | DSM Biomedical Dental Bone Graft Plus | NPM | Substantially Equivalent | |
| K163621 | Vitoss Bioactive (BA) Injectable | MQV | Substantially Equivalent | |
| K161447 | HydroSet XT | MQV | Substantially Equivalent | |
| K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip | MQV | Substantially Equivalent | |
| K153306 | Imbibe Needle | KNW | Substantially Equivalent | |
| K143716 | DSM Biomedical DPR Cable | JDQ | Substantially Equivalent | |
| K140868 | STRYKER KWIC NEEDLE | HAW | Substantially Equivalent | |
| K140414 | IMBIBE NEEDLE | LXH | Substantially Equivalent | |
| K121310 | MESOTHELIUM DENTAL MEMBRANE | NPL | Substantially Equivalent | |
| K112888 | MESO WOUND MATRIX | KGN | Substantially Equivalent | |
| K103787 | MEDEOR MATRIX | FTM | Substantially Equivalent | |
| K103173 | VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K101171 | ORTHOVITA PEEK SPACER | ODP | Substantially Equivalent | |
| K102545 | FM-02 BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K091618 | VITOMATRIX | LYC | Substantially Equivalent | |
| K094061 | KENSEY NASH ECM SURGICAL PATCH | FTM | Substantially Equivalent | |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | NPL | Substantially Equivalent | |
| K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | FTM | Substantially Equivalent | |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | NPL | Substantially Equivalent | |
| K080108 | CORTOSS BONE AUGMENTATION MATERIAL | NDN | Substantially Equivalent | |
| K083033 | VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K081439 | VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 | QEZ | Substantially Equivalent | |
| K073162 | SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING | DQX | Substantially Equivalent | |
| K071695 | KENSEY NASH MACROPORE SHIELD | FTL | Substantially Equivalent | |
| K072384 | MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE | MQV | Substantially Equivalent | |
| K072184 | VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K072195 | THROMCAT THROMBECTOMY CATHETER SYSTEM | MCW | Substantially Equivalent | |
| K071237 | COPIOS BONE VOID FILLER SPONGE AND PASTE | MQV | Substantially Equivalent | |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | NFA | Substantially Equivalent | |
| K060917 | KENSEY NASH BONE VOID FILLER | MQV | Substantially Equivalent | |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | NFA | Substantially Equivalent | |
| K061030 | BIOBLANKET SURGICAL MESH | FTM | Substantially Equivalent | |
| K060016 | THROMCAT THROMBECTOMY CATHETER SYSTEM | MCW | Substantially Equivalent | |
| K060092 | QUICKCAT EXTRACTION CATHETER | QEZ | Substantially Equivalent | |
| K052173 | VITAGEL SURGICAL HEMOSTAT SPRAY SET | FMF | Substantially Equivalent | |
| K043259 | BIOBLANKET SURGICAL MESH | FTM | Substantially Equivalent | |
| K050795 | IMBIBE BONE MARROW ASPIRATION NEEDLE | KNW | Substantially Equivalent | |
| K042040 | TRIACTIV SYSTEM | NFA | Substantially Equivalent | |
| K041923 | BIOBLANKET | FTM | Substantially Equivalent | |
| K032288 | VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL | MQV | Substantially Equivalent | |
| K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K032130 | VITOSS-FILLED CARTRIDGE | MQV | Substantially Equivalent | |
| K032409 | VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER | MQV | Substantially Equivalent | |
| K030208 | IMBIBE II SYRINGE | FMF | Substantially Equivalent | |
| K023074 | IMBIBE BONE MARROW ASPIRATION SYRINGE | FMF | Substantially Equivalent | |
| K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR | LZN | Substantially Equivalent | |
| K011087 | ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE | FMF | Substantially Equivalent | |
| K994337 | VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER | MQV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2530154 | 1000307073 | DSM Biomedical, Inc. | 735 Pennsylvania Dr, EXTON, PA 19341 US | 2026 | and 19 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QEZAspiration Thrombectomy Catheter
- NPLBarrier, Animal Source, Intraoral
- NPMBone Grafting Material, Animal Source
- LYCBone Grafting Material, Synthetic
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
- MCWCatheter, Peripheral, Atherectomy
- LZNCement Obturator
- NDNCement, Bone, Vertebroplasty
- JDQCerclage, Fixation
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- MQVFiller, Bone Void, Calcium Compound
- NOXFiller, Bone Void, Synthetic Peptide
- KNWInstrument, Biopsy
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- GCJLaparoscope, General & Plastic Surgery
- FTMMesh, Surgical
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement
- OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
- PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- FTLMesh, Surgical, Polymeric
- JDZMixer, Cement, For Clinical Use
- GAANeedle, Aspiration And Injection, Disposable
- HAWNeurological Stereotaxic Instrument
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- JEYPlate, Bone
- GWOPlate, Cranioplasty, Preformed, Alterable
- ORGPlatelet And Plasma Separator For Bone Graft Handling
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- HWCScrew, Fixation, Bone
- MQPSpinal Vertebral Body Replacement Device
- JDRStaple, Fixation, Bone
- GAPSuture, Nonabsorbable, Silk
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
- DQXWire, Guide, Catheter
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
Showing 25 of 31| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2772-2015 | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone | Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration | Class II | Terminated | |
| Z-1353-2015 | Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. | Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time. | Class II | Terminated | |
| Z-0938-2015 | Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood. | There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle. | Class II | Terminated | |
| Z-0937-2015 | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement. | There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle. | Class II | Terminated | |
| Z-1399-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1398-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1397-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1396-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1395-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1394-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1393-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1392-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1391-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1390-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1389-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1388-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-1387-2013 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use. | Class II | Terminated | |
| Z-0431-2013 | Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge. | When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T | Class II | Terminated | |
| Z-1623-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 30mm X 40mm REF 20650-03 6280-03 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection, | Terminated | ||
| Z-1622-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 20mm X 30mm REF 20650-02 6280-02 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection, | Terminated | ||
| Z-1621-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 15mm X 20mm Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. | Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection, | Terminated | ||
| Z-3188-2011 | Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material | Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double pouches and there have been no report | Terminated | ||
| Z-1115-2007 | ThromCat Thrombectomy Catheter System. Catalog number 63000-01 | Defective component (power supply) | Terminated | ||
| Z-0835-2007 | ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box. | Insufficient wire sealing | Terminated | ||
| Z-0834-2007 | FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box. | Insufficient wire sealing | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain