7 results
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10ms
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Sources: EU EUDAMED, US FDA
Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
FDA Enforcement
Class II
·Terminated·Jarvik Heart Inc·December 26, 2018
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Tornier, Inc·August 5, 2015
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·November 19, 2014
Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.
FDA Enforcement
Class II
·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·October 1, 2014
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020