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

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DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

JOE LUB HELMET CONDOM

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

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 2, 2026

STAR S4-IR-ETL

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code LZS·April 26, 2013

KNIFE

FDA Adverse Event
Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·April 22, 2011

ETHICON

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code GAO·July 11, 2008

CT EXPRES

FDA Adverse Event
Injury ·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023

UNSPECIFIED BD SMARTSITE EXTENSION SET

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·June 22, 2023

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018