24 results
·
22ms
·
Sources: EU EUDAMED, US FDA
GRAFTSAVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NA
FDA UDI
Stryker GmbH·00886385005652·Cortical Screw, Self-tap., T10 Drive
ZEUS-P
FDA UDI
SPINAL ELEMENTS, INC.·00840606160926·FLAT PADDLE DISTRACTOR, 15MM
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
FDA 510(k)
FDA Class 2
·Radiology
INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
IBP ELB INT. ULNA LRG RGT LNG STM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·June 24, 2016
UNKNOWN IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWA·July 6, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 9, 2013
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS, INC.·Product code HQL·February 25, 2011
VITALITY DS
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021
TPRLC 133 T1 PPS HO 15X150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWL·October 25, 2021
REVISION SHELL LINER CEMENTED 0 DEGREE LINER FACE ANGLE 40 MM I.D.
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·October 26, 2021
BONE SCR 6.5X20 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021
BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021
BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021
BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021
G7 SCREW 6.5MM X 45MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 25, 2021
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
FDA Enforcement
Class II
·Terminated·Amd Ritmed·April 6, 2016
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
FDA Recall
Terminated
·Amd Ritmed 1200 Av 55e Lachine Canada·Product code MHW·February 24, 2016