19 results
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27ms
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Sources: EU EUDAMED, US FDA
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