19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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