22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
FDA 510(k)
FDA Class 2
·Cardiovascular
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776374051·Joseph Scissors, 5 1/2", straight, sharp/sharp
ARGELITE 55
FDA UDI
ARGEN CORPORATION, THE·D818100278·Alloy other noble metal
MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control
FDA UDI
Microgenics Corporation·00884883001824·
Young PerioDT
FDA UDI
Young Innovations, Inc.·00840326420348·Young PerioDT Gel Biofilm Debridement Sulfonate...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780413820·Integra® Jarit® Joseph Scissors, 5-5/8", Straight
Dark Star Deformity
FDA UDI
Republic Spine, LLC·B0751002780·Reduction tab breaker
MAYO DISSECTING SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046993·MAYO DISSECTING SCISSORS CURVED TUNGSTEN CARBID...
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707054540·.016X.016 UPPER NITANIUM® UTILITY ARCHWIRE 38MM
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319736418·Wagner Plastic Surgery Scissors 4-3/4" (12.1cm)...
TPS
FDA UDI
STRYKER CORPORATION·07613327116540·TPS Universal Pla Ster Case Large
VIVANT MEDICAL BIOPSY MARKER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFIED STRAIGHT FIRE LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DELTA TT PRO
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code LPH·January 2, 2026
REFLECTION
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·May 8, 2013
ABBOTT M2000SP
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 24, 2011
CAPSURE EPICARDIAL LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·September 20, 2024