19 results · 21ms · Sources: EU EUDAMED, US FDA

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NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Regent

FDA UDI
SPINAL ELEMENTS·00840916114800·Regent ACP 2-Level, 26mm

ITOTAL IDENTITY TIBIAL CUT GUIDE SMALL RIGHT

FDA UDI
Conformis, Inc.·00810933030537·

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014605180·MAQUET/SIEMENS 1130 3.25" SOFTCARE PLUS

Slimplicity Anterior Cervical Plate System

FDA UDI
PRECISION SPINE, INC.·00815362021170·2 Level 26mm Plate

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450180839·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450180389·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450179369·

VERDICT -II METHAMPHETAMINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

QUICK COMBO PAD

FDA Adverse Event
Injury ·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997

CATHETER MOUNT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZO·July 22, 2008

ATLAS PLUS DR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013

VASOVIEW HEMOPRO 2 EVH SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·April 7, 2011

PRODIGY LG STAT LNG LT 15.0MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 18, 2008

Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

ADVIA CENTAUR TOXOPLASMA M (TOXO M)

FDA Adverse Event
Injury ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·October 22, 2012

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014