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

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Extension Set with BD Q-Syte Luer Access Split Septum

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII

Novo Surgical Inc.

FDA UDI
NOVO SURGICAL, INC.·00842331158933·ferguson operating & suture scissors, blunt/blu...

LEONE SPA

FDA UDI
LEONE SPA·08033707011491·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 27

IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

BASIX COMPAK INFLATION SYRINGE KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011

WHEELCHAIR COMPONENTS

FDA Adverse Event
Malfunction ·INVAMEX·Product code KNN·October 6, 2014

PELVICOL ACELLULAR COLLAGEN MATRIX

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 25, 2013

EON MINI RECHARGEABLE IPG

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 22, 2011

DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

FDA Enforcement
Class II ·Terminated·Ameditech Inc·November 25, 2015

Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·July 2, 2014