23 results · 24ms · Sources: EU EUDAMED, US FDA

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PASCAL STREAMLINE 577 (WITH ACCESSORIES)

FDA 510(k)
FDA Class 2 ·Ophthalmic

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167310111108110·

ERBE ESU MODEL VIO 100 C WITH ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MODALIXX

FDA 510(k)
FDA Class 2 ·Radiology

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 9, 2023

LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2022

HEARTMATE II LVAD

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·May 9, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011

PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·August 30, 2022

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

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025