12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HotDog Warming Mattress + Return Electrode
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2308669·Universal guide tube MicroDrive, for IMM, FHT ...
CADD CASSETTE 100ML W/FLOWSTOP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LHI·April 22, 2022
BIOLIGHT BIODYNAM
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNTHES ANTERIOR CSLP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 20, 2022
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·May 20, 2022
WARM TOUCH BLOWER MODEL 5800
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·November 6, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
GLUCOSE MONITORING SYS/KIT
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021