15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTBLOCK PAIN PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108698114·Titanium Base Abutment Round, Conical L6mm H3mm...
Australis ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127787·
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023218·
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
FDA 510(k)
FDA Class 2
·Neurology
Crescendo Meniscal Insert PS 11mm Size 3
FDA UDI
AMPLITUDE SAS·03701089525107·
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 10, 2021
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 14, 2021
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 9, 2026
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC.·Product code CBK·April 21, 2011
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-CALIF·Product code NJE·April 22, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016