28 results
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28ms
·
Sources: EU EUDAMED, US FDA
BRACHYSEED
FDA 510(k)
FDA Class 2
·Radiology
Sledgehammer
FDA UDI
Keystone Industries·H66810004751·HC 5 lb Pwd & 1 Qt Liq Kit, Clear
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116470·NobelBiocare™ Tri-Lobe-compatible NP Straight M...
Maxizyme Tablets
FDA UDI
HENRY SCHEIN, INC.·00304040028896·Maxizyme Enzymatic Ultrasonic Cleaning Tablets
Implant Prosthetics
FDA UDI
Preat Corporation·00842092130933·NobelBiocare™ Tri-Lobe-compatible NP Straight M...
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640332475553·PLATE BENDER 2
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004750·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004750·
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
FDA 510(k)
FDA Class 2
·Anesthesiology
HARDYDISK TICARILLIN 75MCG
FDA 510(k)
FDA Class 2
·Microbiology
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 28, 2025
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 23, 2021
URETEROSCOPE 6.9/8.4 FR. X 430 MM, 5°, STRAIGHT OCULAR, 3.7 FR. 2.6 FR. CHANNEL
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FGB·December 4, 2024
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·March 12, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 15, 2011
ZENITH RENU CONVERTER AAA ANCILLARY GRAFT
FDA Adverse Event
Injury
·COOK INCORPORATED·Product code MIH·February 21, 2008
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 13, 2023
BrightView SPECT (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
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012