18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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