9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNERMEDIR CAL I AND SYNERMED IR CAL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VARIAX
FDA UDI
Stryker GmbH·07613327370522·F&A Instruments Tray, Lower Tray (Base)
NXSTAGE PUREFLOW SL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OASIS MRI System
FDA 510(k)
FDA Class 2
·Radiology
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·April 18, 2014
LAMITRODE 88 60CM SURGICAL LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·December 21, 2010
KIT 11.5X9.5 CE MAHURKAR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·December 20, 2012
PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026