16 results · 25ms · Sources: EU EUDAMED, US FDA

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CARETEX SURGEON'S HOODS

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

Cortina [MAX] Lumbar Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054

FDA 510(k)
FDA Unclassified ·Unknown

FREESTYLE FREEDOM

FDA Adverse Event
Injury ·Product code NBW·October 22, 2010

ATLAS PLUS HF CRT-D

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

ASR UNI FEMORAL IMPL SIZE 49

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·December 19, 2012

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·June 5, 2019

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·August 10, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·October 23, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·August 3, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·June 5, 2018

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·July 5, 2019

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·March 12, 2020

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·June 5, 2019

a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

FDA Enforcement
Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

FDA Enforcement
Class II ·Completed·Townsend Design·January 17, 2024