15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Blue Nitrile Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106471·MANHATTAN E & E SUTURE FCPS W/ PLATFORM
Midmark
FDA UDI
MIDMARK CORPORATION·00841709108945·The Midmark UltraComfort Concept LR Dental Chai...
FORMATK MAGMA PLATFORM LASER
FDA Adverse Event
Injury
·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019
CENTURION PRESSURE INJECTABLE EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
ZIMMER COLLAGEN REPAIR PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUVUE MOIST
FDA Adverse Event
Injury
·JOHNSON AND JOHNSON VISION CARE, INC.·Product code LPL·August 23, 2022
SOLID SCREWDRIVER, SMALL
FDA Adverse Event
Malfunction
·CONVENTUS FLOWER ORTHOPEDICS·Product code HXX·August 17, 2021
FORMATK MAGMA PLATFORM
FDA Adverse Event
Malfunction
·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020
FORTIFY VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·February 18, 2015
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024