199 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Advanced Instruments GloCyte® Count Template Cartridge
FDA UDI
Advanced Instruments, LLC·00816068020245·For In Vitro Diagnostic Use. Advanced Instrume...
OmniLab Advanced Plus
FDA UDI
Respironics, Inc.·00606959038134·BiPAP Hybrid A30 Ventilator, SpO2, Japan
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK111151·DD tempMED are pre-colored dental milling blank...
ALANTE, BATTERY OPERATED POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
FDA 510(k)
FDA Class 2
·Cardiovascular
HLM TUBIN GSET W/BIOLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 23, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 2, 2011
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 25, 2015
HLM TUBING SE4T W/BIOLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 29, 2015
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 29, 2016
BE-PLS 2050 # PERMANENT LIFE SUPPORT SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTR·March 12, 2015
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DWE·April 23, 2015
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·May 27, 2015
BE-HLS 7050#HLS SET ADVANCED 7.0
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTQ·December 9, 2014
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 17, 2015
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·May 13, 2015
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·May 15, 2015