14 results · 28ms · Sources: EU EUDAMED, 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