14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Implantswiss Dental Implant System and Implantswiss Dental Abutment System
FDA 510(k)
FDA Class 2
·Dental
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
FDA 510(k)
FDA Class 1
·General Hospital
AMPLATZER DUCT OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MAE·October 20, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 11, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 2, 2013
UNKNOWN SHOULDER GLENOSPHERE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·November 5, 2019
UNKNOWN SHOULDER LOCKING SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·November 5, 2019
UNKNOWN SHOULDER METAGLENE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWS·November 5, 2019
UNKNOWN SHOULDER LOCKING SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·November 5, 2019
UNKNOWN SHOULDER HUMERAL CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·November 5, 2019
UNKNOWN SHOULDER IMPLANT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWS·November 5, 2019
UNKNOWN SHOULDER HUMERAL STEMS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWS·November 5, 2019
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021