15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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