19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SpeedLyser Infusion Catheter Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 8, 2017
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·January 8, 2021
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 20, 2011
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 14, 2013
UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 11, 2008
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·August 14, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRB·August 23, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·August 23, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·March 13, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·November 8, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·October 25, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRB·September 14, 2018
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024