15 results · 22ms · Sources: EU EUDAMED, US FDA

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MAXCEM 2

FDA 510(k)
FDA Class 2 ·Dental

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INSIGHT MILLENNIUM III

FDA 510(k)
FDA Class 2 ·Physical Medicine

OMNIGUIDE BEAMPATH FIBER AND ADAPTER

FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010

VERCISE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 12, 2018

OLYMPUS ESG-100, 100...120 V~,

FDA Adverse Event
Injury ·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022

DELTAPLUSH - CERECYTE MICROCOIL

FDA Adverse Event
Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·April 23, 2013

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2011

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

FDA Recall
Terminated ·SteriGear, LLC·Product code FCN·January 11, 2011

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

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022