22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BrainInsight
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743748·ACHIMED ACHILLES SUPP SAND V
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776162368·Conical Trocar Obturator 8mm diameter, 150mm le...
VALULINE
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975010322·
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318010·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD ...
4PK LOCKING SCRW 2025 SLFDRILL
FDA Adverse Event
Injury
·DEPUY IRELAND - 3015516266·Product code HSD·December 16, 2025
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BACT/ALERT FN CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019911535·Narrow PLIF Cage Peek 15 degree 22 x 8 X 11
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019911528·Narrow PLIF Cage Peek 15 degree 22 x 8 X 10
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019911542·Narrow PLIF Cage Peek 15 degree 22 x 8 X 12
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019911580·Narrow PLIF Cage Peek 15 degree 22 x 8 X 16
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019911566·Narrow PLIF Cage Peek 15 degree 22 x 8 X 14
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019911573·Narrow PLIF Cage Peek 15 degree 22 x 8 X 15
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019911559·Narrow PLIF Cage Peek 15 degree 22 x 8 X 13
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·October 30, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·August 23, 2011
HAND PIECE FOR BATTERY POWERED DRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GZL·July 11, 2013
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