9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
FDA 510(k)
FDA Class 2
·Microbiology
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2308689·Universal guide tube for MicroDrive, for IMM, F...
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776324711·Weil Blakesley Forceps Size 00
SI-Restore Sacroiliac Joint Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
NUVASIVE DECADE LATERAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NELLCOR OXIMAX N-600X PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·November 6, 2008
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 1, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024