15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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X-TIP INTRAOSSEOUS PERFORATOR
FDA 510(k)
FDA Class 1
·Dental
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79905111·Sprint II Bracket McLaugh/Benn/Trev. .022" max....
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79905110101·Sprint II Bracket McLaugh/Benn/Trev. .022" max....
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79905111001·Sprint II Bracket McLaugh/Benn/Trev. .022" max....
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79905110051·Sprint II Bracket McLaugh/Benn/Trev. .022" max....
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
FDA 510(k)
FDA Class 2
·Cardiovascular
MOBILE X-RAY UNIT
FDA 510(k)
FDA Class 2
·Radiology
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUAD-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VEMO 7000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 5, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·August 8, 2014
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025