10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
syngo.CT Applications
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111293382·SKLARLITE OLSEN-HEGAR NH 5.5"
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369719·FOOT SUPPORT PEDIATRIC
SINGLE USE GROUNDING PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WIROBOND C
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 11, 2024
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·November 4, 2008
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 2, 2011
COROX OTW-L 85-BP
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NKE·July 17, 2013
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016