15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GRADIA®
FDA UDI
Gc America Inc.·D0470019781·GRADIA® DIRECT Unitips: 10 tips 0.16 mL B3
GRADIA®
FDA UDI
Gc America Inc.·14548161073608·GRADIA® DIRECT Unitips: 10 tips 0.16 mL B3
D-Series Size 1.5 Posterior LIME Bite Block 3-Pack
FDA UDI
CLIKTECH LLC·00856200001978·D-Series Size 1.5 Posterior LIME Bite Block 3-Pack
BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 20, 2017
ANATOMIC TOTAL KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 23, 2026
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 1, 2026
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 13, 2013
COULTER LH 750 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LOQ·February 27, 2011
ULTRASOFT LANCING DEV
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code FMK·February 21, 2008
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
FDA Enforcement
Class II
·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012