64 results · 32ms · Sources: EU EUDAMED, 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...