21 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HEMOSIL PROTEIN S ACTIVITY ASSAY
FDA 510(k)
FDA Class 2
·Hematology
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304008113·
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM
TRIG Reagent Kit
FDA UDI
MEDICA CORPORATION·00386100002121·Triglycerides Reagent Kit for use with EasyRA A...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197116244·Thies Chisel
6 1/4"...
Portex
FDA UDI
ICU MEDICAL, INC.·15019517078787·
MR INSPIRE WITH EXTENDED KIT
FDA 510(k)
FDA Class 2
·Radiology
'RAPIDONE'-METHADONE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015
QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
OXYGENRATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2016
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011
45MM ARTICNG LNR CUTR/6 ROW BL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 6, 2008
ARTIC SUN 5000, 115V NA
FDA Adverse Event
Malfunction
·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·September 26, 2017
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·May 8, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 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