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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Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103883·Large Depth Gauge
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
HAIRMAX DUAL 12
FDA 510(k)
FDA Class 2
·Physical Medicine
OCTRODE
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
PORTEX 10.0MM SUCTIONAID TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD.·Product code BTO·April 18, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
ANATOMIC
FDA Adverse Event
Malfunction
·AMPLITUDE·Product code JWH·December 11, 2018
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