32 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Preci-Bar
FDA UDI
Preat Corporation·00842092105139·Preci-Bar Mini Pallax Female 50mm
Vac Attak™
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783003871·Vac Attak Single Jar
Bio-logic
FDA UDI
NATUS MEDICAL INCORPORATED·00382830053655·Tiptrode Gold-Foil Foam Tip for Pediatric
Arena-L®
FDA UDI
SPINEFRONTIER, INC.·00190361006107·Arena-L, 43X28 Lordotic 12 degrees, 11H
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180510384·Multiconnection Decompression Tube - Small Offs...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383500630·Gutta Percha Points is used to root canal filin...
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161011110·Calcar Reamer, 25mm
Batrik Vascular Silicone Ties
FDA UDI
Batrik Medical Manufacturing Inc·00690521014091·Vascular Silicone Ties, Radio Opaque, Sterile, ...
PANORET, MODEL 1000A
FDA 510(k)
FDA Class 2
·Ophthalmic
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
FDA 510(k)
FDA Class 2
·Radiology
ULTRA CATHETER
FDA Adverse Event
Injury
·CURE MEDICAL LLC·Product code KOD·October 27, 2021
ALLURE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807101111141·ALLURE® MB Base Rx .018 UR1 12T 5A 0OF
Drill
FDA UDI
BICON, LLC·00813110029096·2.0mm Pilot Drill with 11.0mm Stop
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 7, 2022
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·April 4, 2023
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 9, 2013
SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER
FDA Adverse Event
Injury
·CONVATEC INC·Product code EXE·September 17, 2014
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 24, 2011
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013