13 results
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26ms
·
Sources: EU EUDAMED, US FDA
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909111252·REVELATION DIAMOND 847-014F - 5 PACK
Folding Readers
FDA UDI
Diversified Products, Inc.·00842894138113·
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024402072·
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
FDA 510(k)
FDA Class 1
·Anesthesiology
ADAS 3D
FDA 510(k)
FDA Class 2
·Radiology
NOVUM IQ
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·January 7, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 30, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
36MM COCR MOD HD -6MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 2, 2022
G7 LONGEVITY 10DEG LNR 32MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·February 2, 2022
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025