7 results
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17ms
·
Sources: EU EUDAMED, US FDA
ENDURANCE R3000
FDA 510(k)
FDA Class 2
·Anesthesiology
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
FDA 510(k)
FDA Class 2
·Ophthalmic
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SIG RP AOX CRV INS SZ4 10
FDA Adverse Event
Injury
·DEPUY IRELAND ? REG. # 9616671·Product code NJL·February 4, 2013
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·December 23, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
PKG, 5MM INSERT, DISSECTING & GRASPER FORCEPS, SERRATED, 45CM, P/N 0250080579 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