14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638021·CoRoent Ant TLIF PEEK, 15x12x34mm 12°
Slim Reamer Handle
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215083458·
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
FDA 510(k)
FDA Class 1
·Microbiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 21, 2023
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
SYNCHRON CX5 DELTA CLINICAL ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
FLEXI SEAL SIGNAL (FMS)
FDA Adverse Event
Injury
·CONVATEC INC.·Product code KNT·October 11, 2016
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; 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