154 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Medos International Sàrl·10886705026227·HD Arthroscope: Compatible with Storz Style 4.0...
Introcan Safety ® 2
FDA UDI
B. BRAUN MEDICAL INC.·04046955746309·INTROCAN SAFETY 2 W PUR 18GX45MM - US
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247621·No-Profile Interbody, 43mm x 30mm x 20mm, 15 Deg
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM59002421060151·Rotary instrument for ENT surgery
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105160·RICH MICRO TRANSPLANT SCISSORS LEFT
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022074·Interface Cable, FastTrack, Chest, Grael
Portex
FDA UDI
ICU MEDICAL, INC.·15019517074093·
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
White ENDOSEAL MTA
FDA 510(k)
FDA Class 2
·Dental
THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 10, 2014
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
TMC SPEEDMTP
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Death
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 27, 2019
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016