47 results
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27ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
FDA Enforcement
Class II
·Completed·Teleflex Medical·October 25, 2017
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
FDA Enforcement
Class II
·Completed·Spectrum Medical Ltd.·October 30, 2024
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO
FDA Enforcement
Class II
·Completed·LEASEIR TECHNOLOGIES SLU·January 28, 2026
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
FDA Recall
Completed
·Acumed LLC·Product code HWC·March 9, 2022
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
FDA Recall
Completed
·Acumed LLC·Product code HWC·March 9, 2022
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
FDA Recall
Completed
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·April 24, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
FDA Recall
Completed
·Product code LHO·February 8, 2024
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
FDA Recall
Completed
·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code DTQ·March 13, 2023
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
FDA Recall
Completed
·VIRTUAL INCISION CORPORATION·Product code SAB·April 23, 2025
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
FDA Recall
Completed
·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JDI·July 12, 2022
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
FDA Recall
Completed
·Abbott Molecular, Inc.·Product code MZP·July 19, 2022
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
FDA Recall
Completed
·Limacorporate S.p.A Via Nazionale 52 Frazione Villanova San Daniele del Friuli Italy·Product code LXH·September 8, 2017
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·April 5, 2023
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
FDA Recall
Completed
·Withings Sas 2 rue Maurice Hartmann Issy les Moulineaux France·Product code DXN·June 11, 2018
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·April 5, 2023
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
FDA Recall
Completed
·Nuwellis Inc·Product code KDI·December 11, 2024
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021