23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTRAOSSEOUS FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cohere
FDA UDI
Nuvasive, Inc.·00887517014009·COHERE TLIF-O Trial, 14x10mm 4°
Baby Gorilla®/Gorilla® Plating System
FDA UDI
Paragon 28, Inc.·00889795099136·Gorilla, Ankle Fx., Medial Distal Tibia Plate, ...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180521441·Bayonetted Pituitary w/Scissor Handle, Straight...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180521458·Bayonetted Pituitary w/Scissor Handle, Up-bitin...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197025058·Scalpel Handle No. 4
gradua...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197066891·Volkmann Retractor 4 teeth
11,5cm...
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
UNKNOWN NEXGEN FLUTED STEM TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·May 24, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 16, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
UNK-CV-SR-ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 13, 2015
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 13, 2015
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 30, 2018
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code ESW·January 30, 2003