13 results
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18ms
·
Sources: EU EUDAMED, US FDA
ELECSYS CK-MB
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799004239·
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799003508·
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660199996·15 degree stab knife, straight NexGen blade, fu...
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295239185·P.F.C. SIGMA TC3 TIBIAL INSERT TRIAL SZ 1.5 12....
MICROSPAN SYSTEM
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code FED·June 8, 2006
EXER-STIM 2
FDA 510(k)
FDA Class 2
·Neurology
FLEXO DENTAL RESIN MATERIAL
FDA 510(k)
FDA Class 2
·Dental
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 14, 2013
HARMONIC ACE + 7
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 28, 2014
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·January 10, 2011
SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024