12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
FDA 510(k)
FDA Class 2
·Neurology
1ML ALLERGIST TRAY W/ 27GX1/2IN. BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·November 30, 2016
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016
DISCOVERY HUMERAL STEM 4X200MM RT FLANGED C
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDC·April 17, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 16, 2011
CARPENTIER-EDWARDS- PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·June 17, 2008
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001423;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015