18 results · 23ms · Sources: EU EUDAMED, US FDA

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Current Health Monitoring System Gen 2 (G2)

FDA 510(k)
FDA Class 2 ·Cardiovascular

CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)

FDA Adverse Event
Death ·CURRENT HEALTH LTD·Product code MSX·September 9, 2024

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III

SOFTSILK

FDA UDI
Smith & Nephew, Inc.·03596010510716·7 X 30 MM SOFTSILK 1.5 SCREW ...

RIGIDFIX

FDA UDI
Medos International Sàrl·10886705000890·RIGIDFIX FEMORAL ST CROSS PIN KIT (2) each ST C...

CHESAPEAKE® Stabilization System

FDA UDI
VB Spine LLC·10888857081789·3-Screw Titanium Implant

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319744413·Tyrell (Iris) Hook 5" (12.5cm), blunt

CLUNGENE

FDA UDI
Hangzhou Clongene Biotech Co., Ltd.·06950921302230·

EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

VERSALUX

FDA 510(k)
FDA Class 2 ·Dental

INTERSTIM

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 19, 2012

NOVOSTITCH PRO MENISCAL RPR SYS 0

FDA Adverse Event
Injury ·CETERIX ORTHOPAEDICS, INC·Product code GAT·March 24, 2022

LIFE VEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 20, 2008

COULTER ACT 5DIFF HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·July 8, 2013

RIGIDFIX PLA 3.3 MM FEM/TIB ST CROSS PIN KIT, CONTAINS 210133 & 210333

FDA Adverse Event
Injury ·DEPUY MITEK·Product code HTY·November 21, 2014

LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.

FDA Enforcement
Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015