12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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