19 results · 27ms · Sources: EU EUDAMED, US FDA

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DR180+OXY

FDA 510(k)
FDA Class 2 ·Cardiovascular

artegral life HD

FDA UDI
Merz Dental GmbH·D7092004007·artegral life HighDefinition posterior lower -M...

n/a

FDA UDI
Ortho Development Corporation·00822409071753·Neck Trial10/12 Hip Stm EXT

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193105567·HA PEEK EVOS Straight, ,7mmx9mmx 26mm , FLAT 0...

Coral

FDA UDI
Seaspine Orthopedics Corporation·10889981136673·Base

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF20040070·2.0mm Cortex Screw, 1.5 Hex, Self-Tapping, 7mm

APOLLO Ankle Fracture Plating System

FDA UDI
Glw, Inc.·18435711003290·APOLLO Ankle Fracture Plates / 1/3 Tubular Plat...

SILICONE GEL BREAST IMPLANT

FDA Adverse Event
Injury ·MCGHAN MEDICAL CORP.·Product code FTR·November 14, 1994

SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS

FDA 510(k)
FDA Class 2 ·Cardiovascular

IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MS26 SYRINGE DRIVER

FDA Adverse Event
Malfunction ·SMITHS MEDICAL INTERNATIONAL LTD. (PREVIOUSLY GRASEBY MEDICAL LTD.)·Product code FRN·June 15, 2006

REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·January 12, 2022

DRILL BIT Ø1.5 L85/60 2FLUTE

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HTW·March 14, 2013

AED10

FDA Adverse Event
Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·January 18, 2011

PFC KEEL TIB TRAY CEM SZ4

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS INC.·Product code JWH·February 26, 2008

STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·January 22, 2026

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

FDA Enforcement
Class I ·Terminated·St Jude Medical Inc.·November 2, 2016