16 results · 21ms · Sources: EU EUDAMED, US FDA

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CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690111672·Modular Stem 17mm x 100mm

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192596·Distal Reamer 17mm (Zimmer)

Sierra

FDA UDI
Seaspine Orthopedics Corporation·10889981094768·Flexible Occipital Drill, 6mm

FORTOSS VITAL BONE GRAFT SUBSTITUTE

FDA 510(k)
FDA Class 2 ·Dental

PHAROS

FDA 510(k)
FDA Class 2 ·Radiology

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Enforcement
Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

OXF ANAT BRG RT SM SIZE 3 PMA

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 24, 2017

BMT 360 2.5MM OFFSET ADAPTER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 24, 2017

CHARGING SYS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 27, 2014

RIATA ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN BENNETT CORP.·Product code CBK·December 9, 2010

BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·November 2, 2020

AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code FZX·November 14, 2016

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Recall
Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025

HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019