12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLU-VEN TK-2
FDA 510(k)
FDA Class 2
·Hematology
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365104244·
Customized Contour Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BATHTUB RAILS
FDA 510(k)
FDA Class 1
·Physical Medicine
. 5.0MM TI LOCKING SCR SLF-TPNG . W/T25 STARDRIVE 40MM-STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 6, 2020
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 5, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 22, 2015
ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code GEI·January 3, 2020
BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·May 20, 2019
ANTIROTATION SCREW FOR FEMORAL NECK SYS 75MM LENGTH - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·May 20, 2019
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018