16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STRYKER SCOPE/INSTRUMENT HOLDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH 60% VENTURI VALVE, GREEN
FDA UDI
Intersurgical Incorporated·05030267127948·INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH...
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 85mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020823·
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981165932·CORTICAL SHANK, SOLID, 6.0 X 85
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987165936·CORTICAL SHANK, SOLID, 6.0 X 85
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450024348·
Durable BP Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935107002·
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376429526·Fenestrated Cannulated Cortical-Cancellous Poly...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523129508·8.5mm Implant Caddy for 6.0mm Rod
PORTSETT
FDA 510(k)
FDA Class 2
·General Hospital
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
ZELTIQ COOLCORE (6.3)
FDA Adverse Event
Injury
·ZELTIQ AESTHETICS INC.·Product code OOK·April 11, 2013
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 15, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2008
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024