14 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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IIF-A-N-DNA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517359575·CoRoent Small Interlock Base, Case
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127116·AK3 PS Notch Reamer Guide Size 6/5+
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014631165·SurgyCut J - Hook with Handle Electrode, 5mm/35cm
discovery®
FDA UDI
DENTAURUM GmbH & Co.KG·J011790106000·discovery® Bracket, - 7° Torque, 0° Angulation ...
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014632186·SurgyCut J - Hook with Handle Electrode, 5mm/45cm
Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
FDA 510(k)
FDA Class 2
·Cardiovascular
PRELUDE ONE
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
INTERLINK PACLITAXEL SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·August 10, 2010
BD ALARIS¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024