13 results · 32ms · Sources: EU EUDAMED, US FDA

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Uro-G Cystoscope

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

OsteoMed

FDA UDI
OSTEOMED LLC·00845694049504·ExtremiLOCK Ankle Plate Removable Tray

ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SUREONE INSULIN SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

HANDPIECE MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 28, 2018

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code OUT·May 30, 2013

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code OUT·May 30, 2013

PULSE GEN MODEL 102

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·October 17, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 2, 2013

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Malfunction ·COVIDIEN·Product code OUT·December 23, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

FDA Enforcement
Class II ·Terminated·Cook Inc.·July 1, 2015