78 results · 20ms · Sources: EU EUDAMED, US FDA

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Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F)

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F)

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F)

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235817·PLATE 6190027 ANTERIOR CERVICAL 27.5MM

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000868055·PLATE 6190027 ANTERIOR CERVICAL 27.5MM

DemarkQ

FDA UDI
Light Tree Ventures Europe B.V.·08720299044227·The DemarkQ is an Over-the-Counter (OTC) device...

Q-Rejuvalight Pro Facewear

FDA UDI
Light Tree Ventures Europe B.V.·08719327598719·

Q-Rejuvalight Pro Facewear (Model: P19-0023)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NUCLEUS 22

FDA Adverse Event
Injury ·COCHLEAR LIMITED·Product code MCM·May 18, 2025

SteriStay

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

FDA Enforcement
Class II ·Ongoing·Covidien, LP·April 10, 2024

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 21, 2014

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 18, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL