12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single Use Biliary Balloon Dilator
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STRAIGHT PLATE
FDA UDI
Biomet Orthopedics, LLC·00887868004209·
ONLINE DAT PROPOXYPHENE PLUS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2023
PORTEX WRAP STRAP ENDOTRACHEAL TUBE HOLDER
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTR·January 10, 2024
JOSTENT GRAFTMASTER
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MAF·June 3, 2013
ACCUSOL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CASTLEBAR·Product code KPO·June 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
36MM COCR MOD HD -3MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 13, 2020
G7 NEUTRAL ARCOMXL LNR 36MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 13, 2020
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015