9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
FDA 510(k)
FDA Class 2
·Physical Medicine
EndoEssentials™ Absorbent Paper Points 100 - #30 .06 Taper
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015202·Endodontic paper point
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CHURCHILL-HS SUSPENDED NON-VENTED IV SET
FDA 510(k)
FDA Class 2
·General Hospital
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 12, 2010
IN TOUCH ZU
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·November 9, 2012
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024