18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medtronic Confida Brecker Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239869·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE
Non-Shouldered Restorative Kit
FDA UDI
BICON, LLC·00813110025005·5.0 x 6.5mm Non-Shouldered Restorative Kit
EARLYSENSE (EVERON) SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
IMMUNALYSIS COCAINE ELISA FOR HAIR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UNK ACETABLUAR LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·October 7, 2014
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·June 6, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DQY·December 25, 2016
ASAHI GLADIUS EX
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·September 21, 2021
ASAHI GLADIUS EX
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026
METACROSS RX PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·October 15, 2019
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020