18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Trevo NXT ProVue Retriever
FDA 510(k)
FDA Class 2
·Neurology
Lockheed - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal
Bosma Enterprises
FDA UDI
Bosma Enterprises·20818634020196·Nitrile Textured Powder Free Exam Gloves Medium...
CABVI/ High Five
FDA UDI
Ansell Healthcare Product·10076490785021·CABVI 72-1050XR SIZE M (7.5-8.0), Powder-Free N...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105020·Implant Inserter, 14-16mm, Sleeved
MODEL THERMO TEK QUICKCARE
FDA 510(k)
FDA Class 2
·General Hospital
TRIPLEX ER. YAG / ND: YAG SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857184534·Lordotic Trial, Size 28x36x11 mm, 10°
BD MICROLANCE¿ 3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 16, 2022
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 25, 2014
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·August 10, 2011
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013
GALAXY G3 MINI 2MM X 6CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 6, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020