12 results · 20ms · Sources: EU EUDAMED, 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