22 results · 23ms · Sources: EU EUDAMED, US FDA

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TITAN TIBIAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00530181·

Ormco

FDA UDI
ORMCO CORPORATION·00889989014136·EDGW BRKT MED TW 018

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828115018·GEN4 INTERACTIVE

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828117487·GEN4 INTERACTIVE

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828160780·GEN4 INTERACTIVE

STRONGBACK

FDA UDI
STRONGBACK MOBILITY USA, LLC·07640176290183·- Transport wheelchair - Seat width: 18”/45 cm ...

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF20030180·1.5mm Cortex Screw, 1.5 Hex, Self-Tapping, 18mm

KineMatch® PFR System

FDA UDI
Kinamed, Inc.·00818720011035·PATELLA SIZER AND DRILL GUIDE, 36/39mm

BRANEMARK NOVUM

FDA 510(k)
FDA Class 2 ·Dental

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WAVEWRITER ALPHA? PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 8, 2025

V500, SAVINA AND VENTILATORS OF EVITA FAMILY

FDA Adverse Event
Other ·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code JJE·March 13, 2013

FREESTYLE NAVIGATOR

FDA Adverse Event
Malfunction ·Product code LFR·February 28, 2011

RADIESSE

FDA Adverse Event
Injury ·BIOFORM MEDICAL, INC.·Product code LMH·February 25, 2008

BONE PLATE 246 MM LENGTH 8 HOLES

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code HRS·March 23, 2017

2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code LXH·November 10, 2014

Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.

FDA Recall
Terminated ·Stryker Imaging·Product code LMB·August 3, 2009

Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026