17 results · 21ms · Sources: EU EUDAMED, US FDA

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V8 TRANSLUMINAL BAV CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197381369·CERA-CUT® Metzenbaum-Nelson Scissors Fig.1,...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197381352·CERA-CUT® Metzenbaum-Nelson Scissors Fig.1,...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197381345·CERA-CUT® Baby Metzenbaum Scissors curved...

FORZA SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GYRUS PLASMA SKIN RESURFACING SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 19, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·December 7, 2018

ZENIX

FDA UDI
Zoll Medical Corporation·00198843003255·ZENIX, EMS FIRE CONFIGURATION + TEMP

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 30, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·September 8, 2020

ON-X AORTIC PROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·December 8, 2008

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
ANI [ A&I ] GROUP TAIWAN·Product code IOR·May 21, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 25, 2015

TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code MRG·April 19, 2018

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018