26 results · 22ms · Sources: EU EUDAMED, US FDA

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FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

FDA Adverse Event
FUTURE DIAGNOSTICS B.V.·Product code CEW·November 1, 2017

Sledgehammer

FDA UDI
Keystone Industries·H66810004711·HC 1 lb Pwd & 8 oz Liq Kit, Orig

TEWA

FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282503284·TeWa CJ-Type 4015 (s): uncoated acupuncture ne...

Implant Prosthetics

FDA UDI
Preat Corporation·00842092117354·NobelBiocare™ Tri-Lobe-compatible NP Esthetic A...

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167700004710·

MASEL Buccal Tubes

FDA UDI
Ortho Organizers, Inc.·00190707102319·BT 018 ROTH MINI SGL L7R DB (10)

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

QUICK SET PARADIGM

FDA Adverse Event
Malfunction ·Product code FPA·May 20, 2024

CURE™ ACP

FDA UDI
MEDITECH SPINE, LLC·B167S1700004710·

CBYON SURGICAL OPERATING SYSTEM (SOS)

FDA 510(k)
FDA Class 2 ·Neurology

SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

EVIS EXERA II COLONOVIDEOSCOPE

FDA Adverse Event
Injury ·AIZU OLYMPUS CO., LTD.·Product code FDF·November 22, 2024

17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET

FDA Adverse Event
Injury ·COOPERSURGICAL, INC.·Product code MQE·October 25, 2023

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·March 12, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 24, 2011

HEARTMATE XVE LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·February 21, 2008

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

BrightView, Gamma Camera System, Product Code 882480.

FDA Enforcement
Class II ·Ongoing·Philips North America·January 17, 2024

BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016