14 results
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27ms
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Sources: EU EUDAMED, US FDA
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127666·1/8" Drill
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881004000·dentaform® Snap Band,Lower, 1. Molar Band left ...
HMA URIC ACID TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NexGen®
FDA UDI
Zimmer, Inc.·00889024199613·
NexGen®
FDA UDI
Zimmer, Inc.·00889024199620·
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 18, 2014
ESOPHYX2 -04
FDA Adverse Event
Malfunction
·REDMOND·Product code ODE·October 6, 2010
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·November 13, 2012
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.
FDA Enforcement
Class II
·Terminated·Cyberonics, Inc·August 23, 2017
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025