19 results
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22ms
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Sources: EU EUDAMED, US FDA
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SuperNova
FDA UDI
PURELIFE, LLC·D79010612011·SuperNova Nitrile Powder-Free, X-Small, Revolut...
DP-REPAIR
FDA UDI
Denplus Inc·D8451061201·DP-REPAIR-R, SPL, 2.3 kg
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
FDA UDI
Paonan Biotech Co.,Ltd.·04719878787055·Rod Bender
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612011·BioQuick-Brackets FACE Evolution II System .018...
ALPCO MILENIA ANTI-TPO ELISA
FDA 510(k)
FDA Class 2
·Immunology
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
PIRANHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FCL·March 18, 2024
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·March 11, 2025
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code JJE·November 10, 2021
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 16, 2013
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·June 16, 2008
EEA XL 21MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·April 5, 2011
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 29, 2024
SPRINT QUATTRO SECURE S MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 12, 2023
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021