37 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606170·ARMBOARD PAD 26 X 6 X 5" DELUXE TEAL COLOR
iDuo® Patella Sizer
FDA UDI
Conformis, Inc.·00850268007439·iDuo® 41mm Patella Sizer Reusable Instrument
Azur Pure Helical
FDA UDI
Microvention, Inc.·00810170018152·Azur
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0104100·Caddie Lid, Tulip and Domino Connectors
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
FDA 510(k)
FDA Class 2
·General Hospital
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
MR290HFV AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Death
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·August 28, 2009
FORCETRIAD ENERGY PLATFORM
FDA Adverse Event
Injury
·COVIDIEN LP·Product code GEI·April 28, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
DUAL LEAD EXTENSION
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 22, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 24, 2008
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016
COMP RVRS SHDR GLEN BSPLT +HA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 13, 2018
COMP NLK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 13, 2018
E1 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 13, 2018
COMP NLK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 13, 2018
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 13, 2018
COMP NLK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 13, 2018