19 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.

Vitalograph Model 6600 Compact

FDA 510(k)
FDA Class 2 ·Anesthesiology

EBERLE

FDA UDI
Eberle GmbH & Co. KG·04050052016197·Double Meniscus Cutter 4,2

AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)

FDA 510(k)
FDA Class 2 ·Cardiovascular

SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO

FDA 510(k)
FDA Class 2 ·Radiology

AQUILEX FLUID CONTROL SYSTEM

FDA Adverse Event
Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 26, 2014

TAP III

FDA Adverse Event
Malfunction ·AIRWAY MANAGEMENT, INC·Product code LRK·April 29, 2011

REVEL

FDA Adverse Event
Malfunction ·CAREFUSION 203, INC·Product code CBK·October 10, 2015

EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES LLC·Product code NPT·February 6, 2018

5.5 EXP VERSE DI SET SCR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE UNITIZED SET SCR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE CAN SCR 7.0X45

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE CAN SCR 7.0X45

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE DI SET SCR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE UNITIZED SET SCR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE DI SET SCR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE CAN SCR 7.0X45

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

5.5 EXP VERSE DI SET SCR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024