11 results · 21ms · Sources: EU EUDAMED, US FDA

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Medussa-PL Cage

FDA 510(k)
FDA Class 2 ·Orthopedic

Oticon

FDA UDI
Oticon A/S·05707131318718·OPN 2, MRITE 312 2.4G NFM PB C091

SPERMCHECK FERTILITY

FDA 510(k)
FDA Class 2 ·Hematology

LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDFUSION 3500 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL·Product code FRN·May 24, 2013

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·September 11, 2008

TASUKI

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LOX·June 6, 2019

GOLDTRACE FETAL SPIRAL ELECTRODE

FDA Adverse Event
Injury ·CLINICAL INNOVATIONS, LLC·Product code HGP·December 11, 2017

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020