12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306813207·Rees Scissors, Curved, Semi-Sharp, 16.5cm
BIOSCANNER CREATININE TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2
FDA 510(k)
FDA Class 2
·General Hospital
PURACOL PLUS COLLAGEN WOUND DRESSING
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code KGN·April 16, 2026
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·July 28, 2010
UNKNOWN DEPUY PINNACLE CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 10, 2013
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 5, 2011
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015