13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Soniquence Reusable Neutral Plate
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
STRYKER CORPORATION·07613154499656·2.3mm x 16.3mm Tapered Router
Blue Beacon Submucosal Injectable Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIRIDIS DERMA LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Zimmer, Inc.·00889024187795·
Widex
FDA UDI
Widex A/S·05706069794588·Widex BEYOND B-F2 (Cappuccino brown ) 220, Tele...
Widex
FDA UDI
Widex A/S·05706069827439·WIDEX EVOKE EBB3D (Cappuccino brown ) 220, Tele...
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 31, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 12, 2011
EPIC PLUS DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
ARIES SARS-COV-2 EUA
FDA Adverse Event
Malfunction
·LUMINEX CORPORATION·Product code QJR·June 30, 2022
MRHK TIB INS 20MM XS/S S1/S2
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·October 28, 2025
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018