26 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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