12 results
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28ms
·
Sources: EU EUDAMED, US FDA
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVIA® Chemistry APO A1 Reagents
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414517636·Apolipoprotein A1 - ADVIA Chem. - RGT - 2x75 t...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450285930·
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981232085·Capistrano 15x13x10mm Trial with Lateral Hole
MEDICON YASARGIL CLIP APPLYING FORCEPS
FDA 510(k)
FDA Class 2
·Neurology
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
FDA 510(k)
FDA Class 2
·Neurology
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 10, 2013
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·April 12, 2011
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
THE ELECTRODE STORE
FDA Adverse Event
Malfunction
·THE ELECTRODE STORE·Product code GXZ·July 17, 2021
2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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