19 results · 25ms · Sources: EU EUDAMED, US FDA

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BioCare Safety Needles

FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

KDL SYRINGES AND NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...

CASPIAN Spinal System

FDA UDI
VB Spine LLC·10888857242302·Anti Torque Alignment Tube

TARGON FN SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CASCADE BATH, MODEL 6900

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD PLASTIPAK¿ 1 ML SYRINGES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 6, 2022

ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

FDA Adverse Event
Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

FDA Adverse Event
Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

TOTALCARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·May 2, 2013

TAXUS (R) LIBERTÉ (R)

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 2, 2011

PIC

FDA Adverse Event
Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·August 5, 2008

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025