20 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LIFE+CEL OR LIFECEL BATTERY

FDA 510(k)
FDA Class 3 ·Cardiovascular

Cook

FDA UDI
COOK INCORPORATED·00827002141902·Fascial/Urethral Dilator

SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP

FDA 510(k)
FDA Class 2 ·General Hospital

CONFORMANCE CHEMISTRY CONTROL C3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024

880 HUMIDIFICATION SYSTEM

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 23, 2013

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS INC·Product code LYJ·April 13, 2011

MULTI-LINK RX VISION CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·July 1, 2008

880 HUMIDIFICATION SYSTEM

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024

8015 ALARIS SYSTEM PC UNIT

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 22, 2020

LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·April 24, 2017

880 HUMIDIFICATION SYSTEM

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 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