27 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRUST
FDA 510(k)
FDA Class 2
·Dental
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221107150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221107000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221107070·
Cal-Chex A Plus
FDA UDI
STRECK, INC.·30844509000311·A hematology calibrator assayed for the Abbott ...
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003935·Luna Opal MB Mini .022 UL3 D/HK (-7°T +8°A)
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551074282·Ear Forceps, 1.2 x 12 mm, 8 cm
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522211070·
TALOS®-T
FDA UDI
SpineArt SA·07640332475874·TALOS-T (HA) LORDOTIC HA PEEK IBFD 0° L28 W10...
FORTAFLEX SURGICAL SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523149209·Straight Implant Trial 22mm x 11m x 7mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523134038·Tesera ST, 22mm X 11mm X 7mm, Convex, T3
CAPTURE-R INDICATOR RED CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·February 25, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
Widex
FDA UDI
Widex A/S·05706069813159·Widex UNIQUE U-CIC (Dark brown ) 220, Left, RC ...
ATMOSAIR 9000AR MATTRESS
FDA Adverse Event
KINETIC CONCEPTS, INC.·Product code IKY·October 22, 2008
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JLB·August 23, 2011
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 8, 2013
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023