11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FORMATK MAGMA PLATFORM LASER
FDA Adverse Event
Injury
·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
BIO-MINI REVO SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
FORMATK MAGMA PLATFORM
FDA Adverse Event
Malfunction
·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020
UNIFY QUADRA CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVZ·July 7, 2011
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
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 Precise Digital Accelerator, REF MRT 6001, MRT 6011; 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