22 results · 21ms · Sources: EU EUDAMED, 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