24 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMSCO CHIMERON MEDIUM STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
2500 4 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750008032·2500A 4WAY STPCK 22MMOD PORTS
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741120550·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521112055D0·12 x 55 mm Anodized SI Implant Fully Threaded
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674112055060·
REVERSE MEDICAL REFLEX GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
3.25MM SPLINE TWIST IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981319885·Mariner MIS-TAP, Ø5.5mm, 40mm Thread
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857230491·Stop Drill, Epoxy Ring Size 20 mm
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857230477·Stop Drill, Epoxy Ring Size 12 mm
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857230484·Stop Drill, Epoxy Ring Size 14 mm
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 2, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·June 2, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·August 5, 2008
BD NEXIVA 20GA 1.25IN HF Y W/ CAP
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 22, 2022
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024