18 results
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18ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
FDA 510(k)
FDA Class 2
·Cardiovascular
Safco polycarbonate crowns
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310220423·Safco polycar crwn bcspd only 70crwn
AOS CANCELLOUS SCREW 5.0mm x 42.5mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020045·
Symmetry Knapp
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482038369·Symmetry® Scissors, Knapp Dissecting, Straight,...
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575425662·Acetabulum prosthesis trial, reusable - Vario-C...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410220420·Anterior Closing Wedge Osteotomy Guide, 22mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420220420·Anterio Lateral Closing Wedge Osteotomy Guide, ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523126347·Trial / Sizer 42mm OD - 22mm ID
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523105380·Bipolar Implant 42mm OD - 22mm ID
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KINETIC CANNULA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 9, 2022
MULTI-LINK CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·March 26, 2013
RENAISSANCE 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 10, 2011
HOSPIRA PLUM A + INFUSION PUMP
FDA Adverse Event
Injury
·HOSPIRA AND CO.·Product code FRN·March 20, 2008
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018