10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BrainsWay Deep TMS System
FDA 510(k)
FDA Class 2
·Neurology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776419035·Blunt Trocar, 8mm, Extra Long 150mm Length
STALIF C
FDA 510(k)
FDA Class 2
·Orthopedic
DISTAL RADIUS PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·July 27, 2022
MICROFRACTURE AWL 90 DEGREE
FDA Adverse Event
Malfunction
·CONMED LINVATEC·Product code HWJ·October 31, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
PFC SIGMA STAB+ INS 10MM SZ2.5
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 11, 2013
BD MICROLANCE¿ 3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 2, 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