15 results · 22ms · 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.

6420 Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

GF Health Products, Inc.

FDA registration
GF Health Products, Inc.·8 products·🇺🇸 United States

DETLOGIX ANNULOPLASTY RING, MODEL: 5100

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

2183191-1998-00002

FDA Adverse Event
Other ·Product code FMS·September 23, 1998

2183191-1996-00001

FDA Adverse Event
Death ·Product code INX·October 18, 1996

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 26, 2024

DA VINCI S SURGICAL SYSTEM

FDA Adverse Event
Other ·INTUITIVE SURGICAL,INC.·Product code NAY·June 21, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 17, 2014

HERMETIC LUMBAR CATHETER, OPEN TIP

FDA Adverse Event
Injury ·INTEGRA NEUROSCIENCES PR·Product code JXG·October 28, 2015

UNKN GENESIS UNI KNEE IMPL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code HSX·May 9, 2025

UNKN GENESIS UNI KNEE IMPL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code HSX·May 9, 2025

UNKN GENESIS UNI KNEE IMPL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code HSX·May 9, 2025

ADVANTA V12 COVERED STENT

FDA Adverse Event
Injury ·ATRIUM MEDICAL CORPORATION·Product code NIO·February 24, 2021

OT VERIO FLEX METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 31, 2017