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

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CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0100260·Tray Insert, Lumbar Screw Rack 10 x 10

Intess C

FDA UDI
Kalitec Direct LLC·B07309K0100260·Assembly, Caddie, Implants, Hinged

EMBOGOLD MICROSPHERE

FDA 510(k)
FDA Class 2 ·Neurology

Endo Carry-on Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964054363·Endo Carry-on Procedure Kit Includes Basin, Enz...

COMPRESSOR TOP HANDLE

FDA UDI
Osteocentric Technologies, Inc.·00810097802414·COMPRESSOR TOP HANDLE

TERUMO CORP.

FDA registration
TERUMO CORP.·28 products·🇯🇵 Japan

VersaRate

FDA UDI
EMED TECHNOLOGIES CORPORATION·00817708020540·Variable Infusion Flow Rate Controller set

General Instrument

FDA UDI
ORTHOPEDIATRICS CORP.·00841132126509·Pedi Plate Holding Forceps

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER

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

3D-MSPECT

FDA 510(k)
FDA Class 2 ·Radiology

ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

FDA Enforcement
Class II ·Ongoing·Luminex Corporation·August 21, 2019

AXSYM DIGOXIN III

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

UNKNOWN DEPUY CUP

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 2, 2011

ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

FDA Recall
Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

ACHIEVE ADVANCE MAPPING CATHETER

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code DRF·December 20, 2024

HELICAL BLADE COUPLING SCREW

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code LXH·May 19, 2017

FREEDOM60 SYRINGE INFUSION SYSTEM

FDA Adverse Event
Malfunction ·KORU MEDICAL SYSTEMS·Product code FRN·May 1, 2023

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024