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

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AQUAMANTYS PUMP GENERATOR SYSTEM

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

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450279885·

NU-SPEC D

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

SSW-STERILE SOLUTION WARMER

FDA 510(k)
FDA Class 1 ·Physical Medicine

NONE - SEE PHYSICIAN COMMENTS IN H10.

FDA Adverse Event
Injury ·Product code JWH·October 16, 2013

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

AXXESS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013

SCD EXPRESS COMP SYSTEM JAPAN

FDA Adverse Event
Malfunction ·TYCO HEALTHCARE/KENDALL·Product code JOW·May 27, 2008

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 7, 2011

SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020

Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 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