26 results · 35ms · Sources: EU EUDAMED, US FDA

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ART-P3, MODEL P3-1-ART-A1

FDA 510(k)
FDA Class 2 ·Dental

REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM

FDA 510(k)
FDA Class 1 ·Anesthesiology

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 25, 2018

ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·June 18, 2013

ZEPHIR® ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·April 10, 2015

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·November 24, 2017

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·July 12, 2011

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2022

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 10, 2022

SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWE·March 8, 2013

ALLURA XPER FD20 BIPLANE

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code IZI·January 14, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 8, 2014

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 3, 2012

ZEPHIR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·May 15, 2013

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·January 19, 2018

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·January 19, 2018

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·October 17, 2012

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DQO·September 28, 2012