23 results · 32ms · 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.

EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AMARA GEL

FDA UDI
Respironics, Inc.·00606959024915·AMARA GEL MASK WITH RS FRAME WITHOUT HEADGEAR, ...

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036029340·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450205532·

ISODAN

FDA 510(k)
FDA Class 2 ·Dental

OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015

AXXENT FLEXISHIELD MINI (K090417)

FDA Adverse Event
Injury ·XOFT, INC.·Product code IXI·January 7, 2011

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

TRUE BALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 2, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·September 15, 2014