64 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMS SINGLE INCISION SLING SYSTEM (SIS-0)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959001589·ComfortGel Blue Nasal Mask with Headgear, Mediu...
DENTAL ATTACHMENTS
FDA UDI
RHEIN 83 SRL·08059224195209·DISPOSABLE device in plastic material to be emb...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690781·Nylon Ball Abutment Retentive Cap Standard - 13...
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981166267·CORTICAL SHANK, SOLID, 7.0 X 65
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987166261·CORTICAL SHANK, SOLID, 7.0 X 65
CRANIAL STEREOTACTIC EQUIPMENT
FDA 510(k)
FDA Class 2
·Radiology
CAMLOG CYLINDER IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 25, 2025
Arsenal CBx
FDA UDI
ALPHATEC SPINE, INC.·00844856094611·Cortico-Cancellous Reduction Screw 7.0mm X 65mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376492193·Cannulated Fixed Screw Ø7.0mm x 65mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376681764·Cannulated Favored Angle Screw, 7.0mm X 65mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856085374·SACRAL POLYAXIAL SCREW, 7.0mm X 65mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967156514·EXTENDED BODY FIXED SCREW, 7.0mm X 65mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376495507·Cortical-Cancellous Uniplanar Screw Ø7.0mm x 65mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376684758·Cannulated Closed Favored Angle Screw, 7.0mm X ...
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376621647·Polyaxial Screw, 7.0mm X 65mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376499994·Cortical-Cancellous Uniplanar Reduction Screw Ø...
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376490120·Cannulated Cortical-Cancellous Polyaxial Reduct...