11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KIT MENDEC SPINE AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REMEL
FDA UDI
REMEL, INC.·00848838009020·Phenol Red Broth w/1% Xylose 20/PK
BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 26, 2018
3M RELY X VENEER CEMENT TRY-IN PASTER
FDA 510(k)
FDA Class 2
·Dental
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 16, 2017
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
PVC, CLEAR, CONTRAST INJECTION TUBING
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·March 18, 2011
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·June 19, 2008
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