16 results · 11ms · Sources: EU EUDAMED, US FDA

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Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L

FDA Recall
Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

FDA Recall
Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CGA·September 6, 2023

Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

FDA Recall
Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CGA·September 6, 2023

Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987

FDA Recall
Open, Classified ·Alere San Diego, Inc.·Product code CGA·June 24, 2022

HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code CGA·April 24, 2025

RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

FDA Recall
Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CGA·September 6, 2023

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

FDA Recall
Open, Classified ·Alere San Diego, Inc.·Product code CGA·March 1, 2024

Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code FGA·July 23, 2024

The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.

FDA Recall
Open, Classified ·HemoCue AB Kuvettgatan 1 Angelholm Sweden·Product code CGA·May 12, 2025