18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
FDA 510(k)
FDA Class 2
·Radiology
STAR
FDA UDI
Stryker GmbH·00886385017204·Talar Cut Guide Assembly, No Paddle
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037308134·CENTER DRILL BIT Ø3.0mm /AO
Symmetry Malis®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139684·Titanium Malis Style Bayonet Bipolar Forceps, L...
Fixed Drill
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043759·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631113·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631120·
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 27, 2022
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
CLAVE¿ NEUTRAL CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·December 4, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 6, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
BD INTEGRA¿ NEEDLE ONLY 5/8 IN. RETRACTING NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·February 1, 2022
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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