9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
FDA 510(k)
FDA Class 1
·Ophthalmic
artegral
FDA UDI
Merz Dental GmbH·D7091970377·anteriors; shade D2; mould CL
TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GIRAFFE AND PANDA WARMER
FDA 510(k)
FDA Class 2
·General Hospital
11/13 S-ROM 40MM M SPEC+3
FDA Adverse Event
Injury
·DEPUY IRELAND ¿ REG. # 9616671·Product code LPH·February 20, 2013
AIR OPTIX NIGHT & DAY AQUA
FDA Adverse Event
Injury
·PT CIBA VISION BATAM·Product code LPM·January 14, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014
26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·October 19, 2016
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022