23 results · 23ms · Sources: EU EUDAMED, US FDA

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WEARABLE THERAPY GARMENTS

FDA 510(k)
FDA Class 2 ·Neurology

EBERLE

FDA UDI
Eberle GmbH & Co. KG·04050052015930·Aggressive Full Radius Resector 4,2

QCT Pro Asynchronous Calibration Module, CliniQCT

FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...

CoRoent

FDA UDI
Nuvasive, Inc.·00887517637468·CoRoent Ant TLIF PEEK, 14x11x34mm 12°

IMPRUV A.I. CREAM WOUND AND SKIN EMULSION

FDA 510(k)
FDA Unclassified ·Unknown

OSIRIX MD

FDA 510(k)
FDA Class 2 ·Radiology

OSSURE LOEP KIT

FDA Adverse Event
Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

OSSURE LOEP KIT

FDA Adverse Event
Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2014

THREADED GUIDE WIRE ASNIS III Ø2.0X150MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS-SELZACH·Product code LXH·June 3, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·June 27, 2011

OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

FDA Enforcement
Class II ·Terminated·Osteomed, LLC·June 10, 2020

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·November 20, 2017

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·December 19, 2017

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 8, 2019

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 22, 2019

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 29, 2018

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQY·January 26, 2018

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·February 12, 2018

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code PNO·January 29, 2018