19 results · 27ms · Sources: EU EUDAMED, US FDA

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System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE TEST KIT

Pro Advantage

FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P0800633·Pro Advantage HCG Urine Cassette 25/BX

BaseVac

FDA UDI
R. E. Morrison Equipment Inc·D13028000630·1SUR4.16 | 3 User Simplex Surgical Vacuum | NFP...

Pyruvate reagent

FDA UDI
M DIALYSIS INC.·07332699000324·

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197418614·Ring Segment, large 2 piec...

Monitor, Lung Water Measurement

FDA Pre-Market Approval
FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

XR-710

FDA 510(k)
FDA Class 2 ·Dental

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES

Monitor, Lung Water Measurement

FDA Pre-Market Approval
FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code ITI·May 8, 2014

SHILEY

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code JOH·October 17, 2012

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 11, 2010

FEM. MODULAR HEAD - L Ø36MM

FDA Adverse Event
Injury ·LIMACORPORATE SPA·Product code LPH·October 25, 2018

VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

FDA Enforcement
Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025