9 results
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26ms
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Sources: EU EUDAMED, US FDA
FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403
FDA 510(k)
FDA Class 2
·Physical Medicine
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909141252·REVELATION DIAMOND FISSUROTOMY - F - 5 PACK
UC IMU A
FDA 510(k)
FDA Class 2
·Immunology
TRANBERG Thermoguide Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAN AM ULTRA-COMFORT 1/2CC-29GX1/2
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMF·December 7, 2012
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·December 3, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2014
PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080362. 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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015