11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TITAN GEL
FDA 510(k)
FDA Class 2
·Immunology
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100932·DB BRACKET MASTER SERIES MAND RIGHT CUSPID 022 ...
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112897·3M™ Victory Series™ Second Molar Bands, 905-149...
CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
FDA 510(k)
FDA Class 2
·Neurology
POWDER-FREE VINYL GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·January 9, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 22, 2010
ADVANCE(R) II COCR TIBIAL BASE
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code HRY·July 1, 2014
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
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