12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOELLOERS DECARBOXYLASE, ARGININE
FDA 510(k)
FDA Class 1
·Microbiology
Archon
FDA UDI
Nuvasive, Inc.·00887517302083·Archon Screw, 4.0x18mm S.D. Fixed Recon
MAXCUT DIAMOND BURS (6/pk) FINE 8801-018
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781008801181·MAXCUT DIAMOND BURS (6/pk) Shape: Round; Size (...
BARD PARKER
FDA Adverse Event
Malfunction
·ASPEN SURGICAL·Product code GES·January 24, 2022
Arthrex NanoSuture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014
ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2010
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 19, 2012
regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJH·October 20, 2022
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024