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

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FOGARTY OCCLUSION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450722701·

TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)

FDA 510(k)
FDA Class 2 ·Orthopedic

IST SNORING APPLIANCE

FDA 510(k)
FDA Class 2 ·Dental

PELVICOL 2CM X 7CM 1.0MM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·April 24, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 19, 2011

T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE

FDA Adverse Event
Injury ·MERCURY MEDICAL·Product code CAI·September 29, 2015

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·May 7, 2022

NEONATAL PATIENT CIRCUIT KIT

FDA Adverse Event
Injury ·MERCURY MEDICAL·Product code CAI·September 21, 2015

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

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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