13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRA VAGINAL TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Empower Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746072079·DB BKT SL EMPOWER INTERACT LL BIC 022 T-7 A=0 R=0
Empower2
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746013072·DB BKT SL EMPOWER PASSIVE LL BIC 022 T-7 A=0 R=0
Empower Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746121968·DB BKT SL EMPOWER PASSIVE LL BIC 022 T-7 A=0 R=0
Empower2
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746010446·DB BKT SL EMPOWER INTERACT LL BIC 022 T-7 A=0 R=0
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209119295·KIT, REFILL - CUSTOM
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
FDA 510(k)
FDA Class 2
·Anesthesiology
Stryker Neptune 3 Waste Management System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 15, 2023
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 6, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·November 30, 2012
CHOLESTECH
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code CHH·September 27, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024