11 results · 22ms · 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.

SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS

FDA 510(k)
FDA Class 2 ·Orthopedic

BD PRECISIONGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·December 6, 2022

BD PRECISIONGLIDE NEEDLE 30G X 1/2

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·October 12, 2020

URETEX SUP PUBOURETHRAL SLING

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

MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC

FDA 510(k)
FDA Class 2 ·Cardiovascular

CUSTOM PAK

FDA Adverse Event
Malfunction ·ALCON - HOUSTON·Product code KYG·March 20, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011

HI-LO CUFFED ENDOTRACHEAL TUBE

FDA Adverse Event
Malfunction ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code BTR·March 28, 2008

COOK-SWARTZ DOPPLER PROBE

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code ITX·September 6, 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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024