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

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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