Miltex, Inc.
Bethpage, NY, US
Miltex, Inc. appears in FDA device records in Bethpage, NY. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Miltex, 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.
- Integra York PA, Incenforcement report, recall
510(k) clearance history
FDA records hold 23 510(k) clearances for Miltex, Inc. between 1982 and 2010. The busiest year on record is 1982, with 13. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 13 |
| 1995 | 1 |
| 2002 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | KCT | Substantially Equivalent | |
| K092855 | MILTEX MEMBRANE TACK KIT | DZL | Substantially Equivalent | |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | EJI | Substantially Equivalent | |
| K072563 | MILTEX RIGID CONTAINER SYSTEMS | KCT | Substantially Equivalent | |
| K061033 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) | KCT | Substantially Equivalent | |
| K052018 | MILTEX LIGATING CLIP | FZP | Substantially Equivalent | |
| K050570 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | |
| K043013 | MILTEX LAPAROSCOPIC INSTRUMENTS | HET | Substantially Equivalent | |
| K013888 | FIXATION (STEINMANN) PINS | HTY | Substantially Equivalent | |
| K954185 | RE-BAG MULTI-USE POUCH, LARGE & SMALL | KCT | Unknown | |
| K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | ELA | Substantially Equivalent | |
| K823325 | DENTAL INSTRUMENTS - SURGICAL FORCEPS | EMG | Substantially Equivalent | |
| K823324 | DENTAL INSTRUMENTS - PROBES | EIX | Substantially Equivalent | |
| K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | EIY | Substantially Equivalent | |
| K823322 | DENTAL INSTRUMENTS - PLUGGERS | EKG | Substantially Equivalent | |
| K823321 | DENTAL INSTRUMENTS - CARVER | EKH | Substantially Equivalent | |
| K823320 | DENTAL INSTRUMENTS - BONE CHISELS | EML | Substantially Equivalent | |
| K823319 | DENTAL INSTRUMENTS - SCALERS | EMS | Substantially Equivalent | |
| K823318 | DENTAL INSTRUMENTS - EXCAVATORS | EKS | Substantially Equivalent | |
| K823317 | DENTAL INSTRUMENTS - EXPLORERS | Substantially Equivalent | ||
| K823316 | DENTAL INSTRUMENTS - FILES | EKS | Substantially Equivalent | |
| K823315 | DENTAL INSTRUMENTS - KNIVES | EJZ | Substantially Equivalent | |
| K823314 | DENTAL INSTRUMENTS | EJL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EJLBur, Dental
- EKHCarver, Dental Amalgam, Operative
- EMLChisel, Bone, Surgical
- FZPClip, Implantable
- EKGCondenser, Amalgam And Foil, Operative
- EMSCurette, Periodontic
- EKSFile, Pulp Canal, Endodontic
- EMGForceps, Tooth Extractor, Surgical
- EIYInstrument, Filling, Plastic, Dental
- ELAInstrument, Hand, Calculus Removal
- EJZKnife, Margin Finishing, Operative
- HETLaparoscope, Gynecologic (And Accessories)
- HTYPin, Fixation, Smooth
- EIXProbe, Periodontic
- DZLScrew, Fixation, Intraosseous
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- EJISyringe, Cartridge
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0752-2017 | Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures. | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument. | Class II | Terminated | |
| Z-0751-2017 | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures. | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument. | Class II | Terminated | |
| Z-1841-2016 | Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument. | One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle. | Class II | Terminated | |
| Z-2624-2014 | Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid. | Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed. | Class II | Terminated | |
| Z-0862-2009 | Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades. | Blade may break: Over milling of the blade resulted in tip more narrow than specified. | Terminated | ||
| Z-0767-2007 | Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels. | Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex) | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain