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

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EMS PERCUSSOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right

WARMTOUCH COMPACT WARMING UNIT

FDA Adverse Event
Malfunction ·COVIDIEN/FORMERLY TYCO·Product code DWJ·December 23, 2010

BLOCK CEMENT RESTRICTOR (CR) - TITANIUM

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

CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

WARM TOUCH II COMPACT WARMING UNIT

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 2010

PINN CAN BONE SCREW 6.5MMX15MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

SUMMIT POR TAPER SZ6 STD OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

PINN CAN BONE SCREW 6.5MMX25MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

TANDEM T: SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES·Product code LZG·May 14, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 14, 2013

OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING SMALL RT

FDA Adverse Event
Injury ·BIOMET UK LTD·Product code NRA·December 2, 2010

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36

FDA Recall
Open, Classified ·BioPro, Inc.·Product code LZY·September 9, 2025

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36

FDA Enforcement
Class II ·Ongoing·BioPro, Inc.·October 22, 2025

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024