9 results · 17ms · Sources: EU EUDAMED, US FDA

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LAB-SITE(R) SAFETY CANNULA

FDA 510(k)
FDA Class 2 ·Anesthesiology

Ventura NanoMetalene System

FDA UDI
Seaspine Orthopedics Corporation·10889981151065·Ventura NM Trial, 9mm x 24mm x 15mm

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEALTH EXPERT ELCTRONIC STIMULATOR

FDA 510(k)
FDA Class 2 ·Neurology

INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·March 21, 2025

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 22, 2015

PROX*ACCESS 55MM ART STAP THIC

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 21, 2010

ACCU-CHEK ® AVIVA COMBO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 15, 2014

OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.

FDA Recall
Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004