13 results
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29ms
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Sources: EU EUDAMED, US FDA
CEDIA VANCOMYCIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032811·Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl A...
Octane Straight
FDA UDI
Choice Spine, LP·10885862235985·
Octane Straight PC
FDA UDI
Choice Spine, LP·10885862278340·
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
FDA Adverse Event
APPLIED MEDICAL·Product code GDO·March 25, 2013
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON SARL A JOHNSON & JOHNSON COMPANY·Product code FTL·March 29, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 21, 2008
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024