21 results · 37ms · Sources: EU EUDAMED, 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