12 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MINI PATCH
FDA 510(k)
FDA Class 2
·Neurology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016699·Crilewood NH, 8"
GOLDEN GATE ANTERIOR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
FDA 510(k)
FDA Class 1
·General Hospital
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 15, 2016
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 26, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ULTHERA
FDA Adverse Event
Injury
·ULTHERA INC·Product code IYO·September 19, 2014
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWP·June 6, 2011
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 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
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025