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

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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

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

ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D

FDA Recall
Open, Classified ·Welch Allyn Inc Mortara·Product code DPS·September 3, 2021

Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C, X10AXL+ DF - ARD568211710C, X10AXLDUO - ARD568211000C, X10DF - ARD568211110C, X10DF DUO - ARD568211210C, X10DF DUO - ARD568213410C, X10DF DUO - ARD568223510C, X10DF DUO - ARD568224491C, X10DF DUO - ARD568224492C, X10DF DUO - ARD568224493C, X10DF LD - ARD568213110C, X10DF LD X - ARD568223912C, X10DF LD X - ARD568223913C, X10DF V - ARD568224110C, X10DF V XD - ARD568224912C, X10DF V XS - ARD568224911C, X10DF V XS - ARD568224913C, X10LDAXL+ - ARD568213710C, X10LDAXL+ - ARD568243710C, X10SF - ARD568231110C, X10SF - ARD568244911C, X10SF DUO - ARD568231210C, X10SF DUO - ARD568233410C, X10SF DUO - ARD568243510C, X10SF DUO - ARD568244491C, X10SF DUO - ARD568244492C, X10SF DUO - ARD568244493C, X10SF LD - ARD568233110C, X10SF LD X - ARD568243911C, X10SF TRIO - ARD568244440C, X10SF V - ARD568244110C, X10VAXL+ D - ARD568224710C, X10VAXL+ D - ARD568224791C, X10VAXL+ D - ARD568224792C, X10VAXL+ SF - ARD568244710C, X10VAXL+ SF - ARD568244791C, X10VAXL+ SF - ARD568244792C

FDA Recall
Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.

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

Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

FDA Recall
Open, Classified ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code OAS·October 28, 2021

Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

FDA Recall
Open, Classified ·Philips Healthcare·Product code OWB·September 24, 2021

Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FDX·December 28, 2021

Hobbs Medical Cytology Brush Catalog Number: 4204

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FDX·July 29, 2022

Hobbs Medical Cytology Brush Catalog Number: 4206

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FDX·July 29, 2022

Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023

Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·January 20, 2022

YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·January 20, 2022

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

FDA Recall
Open, Classified ·MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China·Product code RHP·October 26, 2021