12 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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