13 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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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