21 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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