14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
FDA 510(k)
FDA Class 1
·Microbiology
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981246822·Interbody, 43mm x 30mm X 18mm, 10 Deg
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221038074·Unitek(TM) Bicuspid Band General Purpose Wide L...
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095604277·Microscope Cover Glass, 22mm x 60mm, # 1 Thickn...
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981266073·Trial, 43mm x 30mm x 18mm, 10 Deg
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011141810000·Polishing brush for handpiece, black
SERFAS ENERGY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3DHJD CAMERA SYSTEM MODEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SiNAPTIC Osteotomy Wedge System
FDA UDI
SINTX Technologies, Inc.·G81711325141810·Osteotomy Wedge System, Cotton Trial 14W x 18D ...
SiNAPTIC Osteotomy Wedge System
FDA UDI
SINTX Technologies, Inc.·G817S111141810·Cotton Wedge, 14W x 18D x 10H
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 3, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 27, 2011
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025