Freudenberg Medical, LLC
Jeffersonville, IN, US
Freudenberg Medical, LLC appears in FDA device records in Jeffersonville, IN. FDA records list 21 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Freudenberg Medical, LLC 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.
- Helix Medical, LLC510(k), enforcement report, recall
510(k) clearance history
FDA records hold 21 510(k) clearances for Freudenberg Medical, LLC between 1989 and 2024. The busiest year on record is 1990, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 3 |
| 1999 | 1 |
| 2002 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2013 | 2 |
| 2019 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240763 | FirstFit Surgical Kit | EWL | Substantially Equivalent | |
| K192422 | Steerable Introducer 12F | DRA | Substantially Equivalent | |
| K191190 | Steerable Introducer | DYB | Substantially Equivalent | |
| K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | LRC | Substantially Equivalent | |
| K131745 | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS | LFB | Substantially Equivalent | |
| K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER | EWL | Substantially Equivalent | |
| K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES | EWL | Substantially Equivalent | |
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | FDF | Substantially Equivalent | |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | EWL | Substantially Equivalent | |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | EWL | Substantially Equivalent | |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | EWL | Substantially Equivalent | |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | EWL | Substantially Equivalent | |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | EWL | Substantially Equivalent | |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | EWL | Substantially Equivalent | |
| K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. | BYD | Substantially Equivalent | |
| K904729 | BLOM-SINGER SHOWER GUARD | EWL | Substantially Equivalent | |
| K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT | EWL | Substantially Equivalent | |
| K900518 | BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT | EWL | Substantially Equivalent | |
| K897005 | BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE | JOH | Substantially Equivalent | |
| K894220 | HOUTS HYSTERECTOMY DRAIN | GBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222140 | 1000121130 | FREUDENBERG MEDICAL, LLC | 2301 Centennial Blvd, Jeffersonville, IN 47130 US | 2026 | |
| 2025182 | 2025182 | Freudenberg Medical, LLC | 1110 Mark Ave, CARPINTERIA, CA 93013 US | 2026 | and 7 more, listed in full below |
| 2031897 | 3008581151 | Freudenberg Medical, LLC | 5050 Rivergrade Rd, Baldwin Park, CA 91706 US | 2026 | |
| 3011241266 | 3011241266 | Freudenberg Medical, SRL | Zona Franca Coyol, La Garita Alajuela 20113 CR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- FCGBiopsy Needle
- MBBBone Cement, Antibiotic
- EPEBrush, Cleaning, Tracheal Tube
- LFBButton, Nasal Septal
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- ENWCatheter, Nasopharyngeal
- GBWCatheter, Peritoneal
- OBICatheter, Pressure Monitoring, Cardiac
- DRACatheter, Steerable
- FDFColonoscope And Accessories, Flexible/Rigid
- BYDCondenser, Heat And Moisture (Artificial Nose)
- KCGDilator, Tracheal
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- JYJGauge, Measuring
- HQJImplant, Absorbable, (Scleral Buckling Methods)
- LRCInstrument, Ent Manual Surgical
- DYBIntroducer, Catheter
- KDDKit, Surgical Instrument, Disposable
- NEUMarker, Radiographic, Implantable
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- EWLProsthesis, Laryngeal (Taub)
- KBESnare, Nasal
- MKYSystem, Skin Closure
- KGXTape And Bandage, Adhesive
- DXOTransducer, Pressure, Catheter Tip
- MMOTray, Surgical, Ent
- JOHTube Tracheostomy And Tube Cuff
- KACTube, Laryngectomy
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2910-2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. | Class II | Open, Classified | |
| Z-2909-2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. | Class II | Open, Classified | |
| Z-1017-2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS) | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia | Class II | Terminated | |
| Z-1016-2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia | Class II | Terminated | |
| Z-0128-2014 | Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body. | Class III | Terminated | |
| Z-2336-2012 | BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional. | Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. | Class III | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain