1,217 results · 22ms · Sources: EU EUDAMED, US FDA

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NAPA EIA ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

REFRESH OPTIVE LENS COMFORT REWETTING DROPS

FDA 510(k)
FDA Class 2 ·Ophthalmic

HP-1 (HEALTHPAX)

FDA 510(k)
FDA Class 2 ·Neurology

QUARTET

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·February 28, 2013

ACCU-CHEK D-TRONPLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·January 20, 2011

8CM ANGLE ATTACHMENT

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·August 6, 2014

Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·February 22, 2012

ADULT DUAL HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 3, 2012

Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

BTT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·August 14, 2007

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·March 15, 2012

ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 20, 2011

ADULT DUAL HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 29, 2013

ADULT BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·January 19, 2009

ADULT INSPIRATORY HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·May 17, 2010

ADULT BREATHING CIRCUIT INSPIRATORY HEATED

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·March 29, 2007

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD·Product code BZE·February 24, 2010

ADULT INSPIRATORY HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·February 23, 2010

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·February 26, 2010