17 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032764·Baltic Denture System BDLoad Ln6 PLSEbil2DFlA1 ...
7F LAUNCHER GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
FDA 510(k)
FDA Class 2
·Orthopedic
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ NORTH AMERICA, INC·Product code LNM·October 17, 2013
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ NORTH AMERICA, INC.·Product code LNM·October 29, 2014
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JIS·March 5, 2012
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
FLEXI-SEAL FMS
FDA Adverse Event
Other
·CONVATEC·Product code KNT·June 7, 2006
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·March 25, 2013
BURETROL IV SOLUTIONADMINISTRATION SET
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·March 29, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·April 22, 2008
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012
FLEXI-SEAL FECAL MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·October 20, 2016
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
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