11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RMI VASCULAR TOURNIQUET KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756350198·TOTAL JOINT PACK
H.A.M., 21-Channel w/ blank insert holes
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024879·
H.A.M.,21-Chan w blank insert holes,Slot
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024886·
EYE-CEPT STERILE SALINE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
IOB Warming Blankets
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PEN NEED UF SHRT 8MM 90S - 31Q5/16
FDA Adverse Event
Malfunction
·BD·Product code FMI·January 7, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 30, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2014
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015