17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WARTIE WART REMOVER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197053129·ROCHESTER- CARMALT Hemostatic Forceps
160mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197382649·ROCHESTER- CARMALT Hemostatic Forceps
200mm,...
HEALICOLL
FDA 510(k)
FDA Unclassified
·Unknown
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
FDA 510(k)
FDA Class 2
·Neurology
UNKNOWN VANGUARD TIBIAL TRAYS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 21, 2017
UNKNOWN VANGUARD BEARINGS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 21, 2017
UNKNOWN VANGUARD TIBIAL TRAYS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 21, 2017
UNKNOWN VANGUARD FEMORALS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 21, 2017
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2014
BOWEL GRASPER INSTRUMENT
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·May 31, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 15, 2011
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
UNKNOWN ZIMMER NCB PLATE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·June 19, 2017
UNKNOWN ZIMMER NCB PLATE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·June 19, 2017
UNKNOWN ZIMMER NCB PLATE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·June 19, 2017
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 24, 2014