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