31 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
FDA 510(k)
FDA Class 2
·Cardiovascular
Bur PM2-70 50K Carb Ø7.0
FDA UDI
Bien-Air Surgery SA·07630055502506·
Dark Star Deformity
FDA UDI
Republic Spine, LLC·B0751002740·Polyaxial Screw head positioner
SleepWeaver Advance - Mask & Headgear - Blue
FDA UDI
CIRCADIANCE, LLC·B036100274·SleepWeaver Advance Cloth Nasal CPAP Mask & Hea...
MAYO DISSECTING SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046979·MAYO DISSECTING SCISSORS STRAIGHT TUNGSTEN CARB...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319736371·Wagner Plastic Surgery Scissors 4-3/4" (12.1cm)...
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707054496·.018 UPPER NITANIUM® UTILITY ARCHWIRE 34MM
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SMR SHOULDER SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·May 18, 2026
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 8, 2013
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·September 18, 2014
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·May 16, 2011
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
BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 22, 2020
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 23, 2020
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 23, 2020
BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 22, 2020
BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 22, 2020
BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 22, 2020