17 results
·
35ms
·
Sources: EU EUDAMED, US FDA
MIDWIFERY/OBSTETRICAL FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORZA
FDA UDI
Orthofix US LLC·18257200077892·CUP CURETTE RIGHT #1 - SERRATED
LARIAT II SUTURE DELIVERY DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MMX12
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code HSB·October 30, 2012
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 3, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 29, 2012
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021
VIDAS® ANALYZER
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJE·June 3, 2021
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012