17 results
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24ms
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Sources: EU EUDAMED, US FDA
TCD 100M, PWD13 TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964019027·Endo Carry-On Procedure Kit
AirLife™
FDA UDI
AIRLIFE·10889483571286·AirLife™ Misty Fast™ Medium Volume High Flow Co...
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0025331·CC/ Dentine D-A3
AirLife
FDA UDI
Carefusion Corporation·10885403039270·Airlife™ Misty Finity™ Medium Volum...
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752115002·AirLife™ Misty Fast™ Medium Volume High Flow Co...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776377175·Morse Sternal Retractor, adult, with 3" deep bl...
SURGIFLATOR-40
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VOCOM IMPLANT- 8MM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
M2A-MAGNUM MOD HD SZ 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 13, 2013
ALLURA XPER FD20
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·January 28, 2011
CODMAN EXTERNAL DRAINAGE SYSTEM III
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MEDOS S.A·Product code JXG·February 26, 2008
Minor Procedure Pack, part number AMS4799
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·January 18, 2017
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·December 19, 2016
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024