15 results · 21ms · Sources: EU EUDAMED, 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