26 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810000740·Amalgam Carrier SE Steel #4
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964000735·Custom Procedure Kit
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540469991·SHUNT PLACEMENT TOOL L 2-4
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555244000074·Palm Handle
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
FDA 510(k)
FDA Class 2
·Cardiovascular
BARCOMED 5MP1H
FDA 510(k)
FDA Class 2
·Radiology
LEEP PRECISION GENERATOR
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·November 13, 2020
ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 CM ULTEM KOH-EFFICIENT
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HEW·May 27, 2026
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code HSD·February 6, 2023
T-FLEX ASPHERIC
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·March 8, 2013
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC·Product code FNL·February 18, 2011
OXFORD PHASE III FEMORAL COMPONENT
FDA Adverse Event
Injury
·BIOMET, INC.·Product code HRY·February 18, 2008
IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
FDA Recall
Terminated
·International Remote Imaging Systems Inc·Product code JJW·April 29, 2005
LEEP PRECISION GENERATOR
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·December 13, 2020
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code PHX·September 12, 2022
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025