9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Eagle S/Saevo Slim/D700 Slim
FDA 510(k)
FDA Class 2
·Dental
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365120183·
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMP TM 3.7MM MTX,13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 29, 2022
HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 17, 2008
ACHIEVA 1.5T NEW
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code LNH·August 17, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021