18 results
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28ms
·
Sources: EU EUDAMED, US FDA
XR-710
FDA 510(k)
FDA Class 2
·Dental
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000630·1SUR4.16 | 3 User Simplex Surgical Vacuum | NFP...
THD SLIDE ONE
FDA UDI
THD SPA·18033737710354·THD Doppler Prbe is intended to be used with TH...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418614·Ring Segment, large
2 piec...
SPECTRUM
FDA UDI
Ortho Arch Company Inc·D9098000631·SPECTRUM DIRECT BOND BRACKET REMOVER - ANGLED
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
MASS CASUALTY VENTILATOR, MODEL MCV100
FDA 510(k)
FDA Class 2
·Anesthesiology
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
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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012