37 results · 32ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

FDA 510(k)
FDA Class 2 ·General Hospital

OsteoMed

FDA UDI
OSTEOMED LLC·00842528102107·4.7 mm Cannulated Over Drill, Standard AO Quick...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694042987·1.6mm x 6mm Screw

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321616060·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311616060·

OsteoMed

FDA UDI
OSTEOMED LLC·00842528108246·4.7 mm Cannulated Over Drill, Standard AO Quick...

VACUTRON

FDA UDI
Allied Medical, LLC·00026072009369·INTERMITTENT SUCTION REGULATORS

DEFIBRILLATOR CABLE TESTER, MODEL DT2200

FDA 510(k)
FDA Class 2 ·Cardiovascular

MICROMED PD-8K INSULATION DEFECT DETECTOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019

LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code FZX·May 1, 2017

LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code FZX·May 30, 2017

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·February 13, 2019

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

VICRYL SUTURE

FDA Adverse Event
Injury ·ETHICON INC, SUBSIDARY OF JOHNSON AND JOHNSON·Product code GAM·June 7, 2013

OLYMPUS ELECTROSURGICAL UNIT

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNS·July 23, 2014

LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·February 28, 2018

HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·February 26, 2020

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·February 26, 2020