17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Droplet Pen Needle 30G & 33G
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568731·CoRoent Ant TLIF Ti, 10x12x34mm 0°
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041485·4.0mm Angled Locking/Compression Drill Guide
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184087·Accufit Molar Bands Lower Left Second Molar 34
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113271·STAB KNIFE 15 DEGREE (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
TRAVELAIR PORTABLE COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EXCOR®
FDA Adverse Event
Injury
·BERLIN HEART GMBH·Product code DSQ·December 12, 2023
GE 3T MRI
FDA Adverse Event
Injury
·GE MEDICAL SYSTEM·Product code LNH·October 15, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 2, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·June 21, 2013
WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·March 6, 2024
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DRC·March 10, 2026
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