13 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Pedimax II - Pedicular Screw Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·July 25, 2018
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·October 15, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 27, 2011
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 20, 2013
8120 ALARIS PCA
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FRN·September 11, 2020
EXPRESSEW III W/HOOK
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code LXH·April 5, 2021
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014