34 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
FDA 510(k)
FDA Class 2
·Cardiovascular
Preci-Bar
FDA UDI
Preat Corporation·00842092105177·Preci-Bar Standard Resil. Pallax Male 50mm
DD Bio Splint P
FDA UDI
Dental Direkt GmbH·EDDIK101151·DD Bio Splint P are transparent dental milling ...
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981256296·Tri-Flat Tap, 11.5mm
BOVINE SERUM, CAT. LNO. 110-1115
FDA 510(k)
FDA Class 1
·Hematology
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383500678·Gutta Percha Points is used to root canal filin...
Arena-L®
FDA UDI
SPINEFRONTIER, INC.·00190361006121·Arena-L, 43X28 Lordotic 12 degrees, 15H
RIVA Pedicle Screw System
FDA UDI
XENIX MEDICAL LLC·00840493414577·Nav Awl-Tip Pedicle Tap, 11.5mm
Healing Plug
FDA UDI
BICON, LLC·00813110024114·Healing Plug Removal Tool - Latch
ULTRA CATHETER SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
FDA 510(k)
FDA Class 2
·Ophthalmic
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBF·October 2, 2025
BE-HLS 7050#HLS SET ADVANCED 7.0
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTQ·December 9, 2014
Widex
FDA UDI
Widex A/S·05706069885552·WIDEX MOMENT MRB0 (Chestnut brown ) RIC 10
SYNGO SUITE FOR ONCOLOGY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012
CURRENT PLUS VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
RESPIRONICS INC·Product code BTI·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021