26 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Redicare
FDA UDI
REDICARE LLC·B70901030071·40 Fabric Knuckle Bandages Latex Free Heavy Wei...
OptiChamber Diamond
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000510·DIAMOND WITH LG MASK-PREFERRED PLUS
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108131·HA PEEK EVOS Straight, ,7mmx9mmx 22mm , FLAT 0...
Altus Spine Cervical Interbody Fusion System
FDA UDI
Altus Spine, LLC·00843210131139·Rasp, No Tab
Stefan Bone Holding Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896121256·Stefan Bone Holding Forceps With Extra Long Rat...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694044820·2.0mm, L Plates 18mm Rigid, Left & Right, with ...
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·August 9, 2016
BELLEGLASS HP ENAMEL 2
FDA 510(k)
FDA Class 2
·Dental
GALAXY
FDA 510(k)
FDA Class 2
·Dental
PROGAV®
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·May 9, 2013
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 19, 2014
M2A MAGNUM PF CUP 62MM X 56MM ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 25, 2011
Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KNW·December 23, 2019
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2014
Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 12, 2020
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·July 25, 2016