22 results · 23ms · Sources: EU EUDAMED, US FDA

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DISPOSABLE INSULIN SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306816307·Balfour Retractor, Open Ended Blades, 5cm Deep,...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450457870·

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

ACRYSOF RESTOR

FDA Adverse Event
Other ·ALCON LABORATORIES, INC./HUNTINGTON·Product code HQL·October 20, 2006

ACRYSOF RESTOR

FDA Adverse Event
Other ·ALCON LABORATORIES, INC / HUNTINGTON·Product code HQL·October 20, 2006

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 25, 2011

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

LEAD MODEL 304

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·September 23, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·April 25, 2011

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 24, 2011

VENTED AUTOFEED CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 7, 2011

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
UNKNOWN·Product code FSA·July 30, 2012

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·May 30, 2012

ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 23, 2011

M2A-MAGNUM MOD HD SZ 50MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·December 31, 2018

Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·August 30, 2017