17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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