20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
FDA 510(k)
FDA Class 2
·Cardiovascular
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00328101·
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032810·Baltic Denture System BDLoad Ln6 PLSEbil2DFl A3...
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049957003265·Gemini Lithotripter, 65 KW
WCM WASTE & COMPLIANCE MANAGEMENT, INC.
FDA registration
WCM WASTE & COMPLIANCE MANAGEMENT, INC.·2 products·🇺🇸 United States
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
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981176372·Plate Lock
COBRASCAN CR-1 FILMLESS
FDA 510(k)
FDA Class 2
·Radiology
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
Octane Straight
FDA UDI
Choice Spine, LP·10885862235978·
Octane Straight PC
FDA UDI
Choice Spine, LP·10885862278333·
EPIX UNIVERSAL CLIP APPLIER
FDA Adverse Event
APPLIED MEDICAL·Product code FZP·March 25, 2013
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 29, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 21, 2008
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022
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