33 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
FDA 510(k)
FDA Class 2
·Cardiovascular
Bur PM2-70 50K Steel Ø5.0 St
FDA UDI
Bien-Air Surgery SA·17630055503838·
Digital Analogue WP
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074567·
COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004270·COOLEY BULLDOG CLAMP CROSS ACTION CURVED
COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002227·COOLEY BULLDOG CLAMP CROSS ACTION CURVED
Flexion Gap Tensioner
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215041465·
LORENZ FIDUCAIL SCREW
FDA 510(k)
FDA Class 2
·Neurology
ELI 230 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 8, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 13, 2011
FOUNDATION KNEE SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·August 6, 2008
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020