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