15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
FDA 510(k)
FDA Class 2
·General Hospital
BioCare Safety Needles
FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"
5800 1WAY VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750008056·5800 1WAY GIANT 2in OD/1.75in ID
16PW - Genesee & Wyoming RR - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588120874·16PW - Genesee & Wyoming RR - Poly White
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809282819841·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390863346·
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
TRUDI SUCTION, 70 - 1PK
FDA Adverse Event
Malfunction
·ACCLARENT, INC.·Product code PGW·February 27, 2023
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 1, 2020
ENDOSCOPE, UTEROSCOPE, VIPER
FDA Adverse Event
Malfunction
·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code FGB·May 2, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHA·June 2, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·August 6, 2008
TRUDI SUCTION, 70 - 1PK
FDA Adverse Event
Malfunction
·ACCLARENT, INC.·Product code PGW·September 30, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021