22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UCP Stem
FDA 510(k)
FDA Class 2
·Orthopedic
XENMATRIX
FDA UDI
Davol Inc.·00801741129018·XenMatrix AB Surgical Graft, 25 cm x 30 cm
LEONE SPA
FDA UDI
LEONE SPA·08033707014485·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 30
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106327·CASTROVIEJO FORCEPS 0.9MM
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575305599·Orthopaedic implant aiming/guiding block, reusa...
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575245246·Orthopaedic implant aiming/guiding block, reusa...
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365119767·
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365121272·
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575245253·Orthopaedic implant aiming/guiding block, reusa...
3DI INCLUDING CSCORE
FDA 510(k)
FDA Class 2
·Radiology
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 27, 2024
ZINGER GUIDE WIRE - CRDM
FDA Adverse Event
Injury
·MEDTORNIC, INC·Product code DQX·June 7, 2013
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code NVY·August 11, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code FZX·November 30, 2023
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 24, 2024
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014