14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033866·Baltic Denture System BDLoad BDLoad Sm6 PLSEbm...
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CONVOY ADVANCED DELIVERY SHEATH KIT
FDA 510(k)
FDA Class 1
·Immunology
NO CODE AVAILABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GXN·March 8, 2016
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·April 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·March 17, 2011
ZENITH RENU CONVERTER AAA ANCILLARY GRAFT
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·April 25, 2008
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 2, 2013
PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GWO·June 21, 2016
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·November 30, 2022
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