11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517390547·CoRoent® XL Wide, 10x22x60mm
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756349611·MINOR PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112267·SURG-I-BAND ORANGE
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112311·SURG-I-BAND BLUE
HANSATOME MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
NEWTOM 5G / NEWTOM 5G VERSION FP
FDA 510(k)
FDA Class 2
·Radiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·November 23, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·July 2, 2014
GO BED PLUS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 19, 2012
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