46 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHILIPS OBTRACEVUE MODEL SW REV. G.00
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Axcent Acrylics
FDA UDI
GARRECO, LLC·D79331004200·Premium Lt Char 20lb
Bur PM2-70 50K Steel Ø1.8 St
FDA UDI
Bien-Air Surgery SA·17630055503760·
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317302427·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002080·Double Row BSSO Plate, 10mm
COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004200·COOLEY BULLDOG CLAMP CROSS ACTION STRAIGHT
COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002197·COOLEY BULLDOG CLAMP CROSS ACTION STRAIGHT
CURE OPEL-C
FDA UDI
MEDITECH SPINE, LLC·B1671100412000·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063401·2.0 OSA 10mm Double Row BSSSO Plate Sterile Qty 2
RUSCH MMG/O'NEIL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·January 12, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·May 8, 2013
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
8800
FDA Adverse Event
Malfunction
·GE MED SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 9, 2010
ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·March 22, 2012
INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·November 23, 2010
iCT, Model # 728306, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019