15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CANNON II PLUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450148440·
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935100324·
Trinity Biotech
FDA UDI
PRIMUS CORPORATION·05391516748186·Hemoglobin variants assay, Ultra2 Resolution 50...
CONTOUR CURVED CUTTER STAPLER CS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006
JETLITE 4000
FDA 510(k)
FDA Class 2
·Dental
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
FDA 510(k)
FDA Class 1
·General Hospital
CATHETER ACCESS PORT KIT
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LKK·April 1, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 5, 2011
DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCW·May 7, 2008
2.7 DEGREE STRAIGHT SAGITAL SAW
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·April 23, 2021
2.7 DEGREE STRAIGHT SAGITAL SAW
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·April 23, 2021
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·August 22, 2018
3.0 RIO® ROBOTIC ARM - MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·September 18, 2019
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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