21 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSSIO Pin Product Family
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197206037·Finochietto Rip Spreader, Child
111x32...
SKINSENSE POLYISOPRENE UNDERGLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
REVOLUTION XR/D
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code KPR·July 21, 2011
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·April 19, 2021
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·December 11, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·November 30, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·December 3, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·November 27, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·September 17, 2020
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·December 7, 2018
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·May 29, 2019
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code FKX·March 3, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 23, 2015
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021