42 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
FDA 510(k)
FDA Class 2
·Immunology
Bur PM2-70 80K FC Ø2.0 St
FDA UDI
Bien-Air Surgery SA·17630055504194·
Osstell SmartPeg Type 42
FDA UDI
Osstell AB·09010522001523·ISQ Measurement Peg
SONTEC SATINSKY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004640·SONTEC SATINSKY BULLDOG CLAMP DOUBLE ANGLED
SONTEC SATINSKY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002357·SONTEC SATINSKY BULLDOG CLAMP DOUBLE ANGLED
Tether™
FDA UDI
Seaspine Orthopedics Corporation·10889981035709·Plate - 4 Level - 64mm
NRFit
FDA UDI
ICU MEDICAL, INC.·10610586043833·
RADCALC, MODEL V.4.0
FDA 510(k)
FDA Class 2
·Radiology
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015
QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
OXYGENRATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2013
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·May 17, 2011
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·August 25, 2020
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·June 14, 2017
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016