9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORTABLE LIFECARE VENTILATOR PLV-102
FDA 510(k)
FDA Class 2
·Anesthesiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920706·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704266627·FRAZIER SUCTION TUBES 7.5" ANGLED 11 FRENCH
URS LP DIGITAL, MILLENNIUM, RADPRO
FDA 510(k)
FDA Class 2
·Radiology
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2014
REFLECTION
FDA Adverse Event
Injury
·BROOKS MANUFACTURING SITE·Product code JDH·November 21, 2012
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2015
PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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