21 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E-Cath
FDA 510(k)
FDA Class 2
·Anesthesiology
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124696·Modular Offset Stem 9mm x 150mm x 2mm
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320912·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320899·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320868·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320905·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320936·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320851·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320875·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320929·Modular Stem,Conical
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575320882·Modular Stem,Conical
CATHASSIST
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRODESSE PROADENO
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
CRIT-LINE BLOOD CHAMBER
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KOC·July 21, 2018
ENRHYTHM
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 8, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 17, 2011
ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023