18 results · 28ms · Sources: EU EUDAMED, US FDA

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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