9 results · 26ms · Sources: EU EUDAMED, US FDA

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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