12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CF-1
FDA 510(k)
FDA Class 2
·Ophthalmic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040067789·MOLAR BAND UL 1ST&2ND 33 (2)
INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
FDA 510(k)
FDA Class 2
·Cardiovascular
SEXTANT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·December 10, 2010
SPACEMAKER BLUNT TIP TROCAR 10MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC·Product code GCJ·March 28, 2013
NEXGEN LPS-FLEX ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·April 14, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORP.·Product code NBW·June 20, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016