11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EpiLaze Multi-wavelength Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Edge™ Diamond ND016-5F Needle
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002547·Diamond dental bur, reusable
SLIM ONEBODY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
POLARIS Q-SWITCH RUBY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESERVOIR 3ML MMT-332A
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FRN·June 15, 2018
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·June 26, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2011
MARLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·September 26, 2008
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 10, 2018
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018