15 results · 20ms · Sources: EU EUDAMED, US FDA

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Ion Endoluminal System (IF 1000)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MAS PLIF

FDA UDI
Nuvasive, Inc.·00887517444783·MAS PLIF Fixation Rod, 70mm Pre-Bent

MaXcess

FDA UDI
Nuvasive, Inc.·00887517197696·MaXcess 4 Blade, 70mm Right

Syntec-Taichung Non-sterile Bone Plate and Screw Implants

FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864684092·Quarter Tubular Plate 2.7 x 7Holes x L55mm

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112564·BARRON CORNEAL PUNCH 6.0MM

FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20

FDA 510(k)
FDA Class 2 ·Hematology

TARGETING ARM PROX. LAT TIBIA LEFT

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012

NA

FDA UDI
Zimmer, Inc.·00889024119659·

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

FDA Enforcement
Class II ·Ongoing·Preat Corp·June 25, 2025

various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017