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

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OSTEOCRETE BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
KEY SURGICAL, INC.·00849771048183·K-Wire and Steinmann Pin Dispensers, .054-inch...

LEONE SPA

FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0310040·Probe, 1.5 inch Ball, Lenke, Straight, Black

General Instrument

FDA UDI
ORTHOPEDIATRICS CORP.·00841132127087·2.2/1.25 Drill Guide

MATIRA ANTERIOR CERVICAL SYSTEM

FDA UDI
Kalitec Direct LLC·B07307K0170040·Driver Shaft, T10 Wedge

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 6, 2025

WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NEEDLELOK HYPODERMIC NEEDLE PROTECTION

FDA 510(k)
FDA Class 2 ·General Hospital

ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01

FDA 510(k)
FDA Class 2 ·Orthopedic

INFANT BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 3, 2008

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·April 22, 2013

SIEMENS BRAND NAME: ARTISTE MV

FDA Adverse Event
Other ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·April 18, 2011

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

Biolox Ceramic Head XL

FDA Recall
Terminated ·Plus Orthopedics·Product code LZO·February 10, 2004

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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