12 results · 19ms · 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.

HYDRASORB JOYCE SPONGE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED

FDA 510(k)
FDA Class 2 ·General Hospital

BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CYLINDER FOAM COVERED ALITEX

FDA UDI
ALIMED, INC.·00733657234671·

CYLINDER FOAM COVERED ALITEX

FDA UDI
ALIMED, INC.·00733657234701·

CYLINDER FOAM COVERED ALITEX

FDA UDI
ALIMED, INC.·00733657234688·

CYLINDER FOAM COVERED ALITEX

FDA UDI
ALIMED, INC.·00733657234695·

LAMITRODE TRIPOLE 16

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 17, 2014

SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Injury ·DEXCOM, INC.·Product code MDS·January 22, 2013

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 8, 2010

GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

FDA Recall
Completed ·DATEX--OHMEDA, INC.·Product code FMZ·June 6, 2023

GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

FDA Enforcement
Class I ·Completed·DATEX--OHMEDA, INC.·November 6, 2024