Medical Device Manufacturer · US , Waukegan , IL

Cardinal Health200, LLC

26 submissions · 26 cleared · Since 2011
26
Total
26
Cleared
0
Denied

Cardinal Health200, LLC — FDA 510(k) Submissions

Cardinal Health200, LLC has submitted 26 FDA 510(k) premarket notifications since 2011, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wrap, Sterilization, Gown, Surgical, Mask, Surgical, Polymer Patient Examination Glove, Syringe, Antistick . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
Cardinal Health Nitrile Exam Gloves
K241780 · LZA Polymer Patient... · General Hospital
Aug 2024 64d
Cardinal Health? SmartGown? EDGE Breathable Surgical Gown with ASSIST? Instrument Pockets
K230838 · FYA Gown, Surgical · General Hospital
Jul 2023 122d
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
K223376 · MEG Syringe, Antistick · General Hospital
Jun 2023 229d
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
K230028 · JOW Sleeve, Limb, Compressible · Cardiovascular
Apr 2023 89d
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K201592 · KGO Surgeon's Gloves · General Hospital
Sep 2021 471d
Nitrile Blue Powder-free Examination Glove
K211390 · LZA Polymer Patient... · General Hospital
Aug 2021 115d
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
K200824 · FYA Gown, Surgical · General Hospital
Jul 2020 121d
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
K193327 · FYA Gown, Surgical · General Hospital
Mar 2020 109d
Cardinal Health? Level 3 Surgical Mask with Anti-Fog Foam Strip
K192374 · FXX Mask, Surgical · General Hospital
Dec 2019 94d
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
K182830 · QPC Gown, Non-sterile,... · General Hospital
Apr 2019 203d
Cardinal Health Sterilization Wrap
K181174 · FRG Wrap, Sterilization · General Hospital
Dec 2018 223d
Cardinal Health Non-Reinforced Surgical Gown
K170762 · FYA Gown, Surgical · General Hospital
Jun 2017 88d
Cardinal Health Sterilization Wrap
K161910 · FRG Wrap, Sterilization · General Hospital
Apr 2017 282d
Cardinal Health Isolation Gown
K160339 · FYC Gown, Isolation, Surgical · General Hospital
Jul 2016 171d
Cardinal Health Sterilization Wrap
K151445 · FRG Wrap, Sterilization · General Hospital
Dec 2015 206d
Cardinal Health Sterilization Wrap
K151788 · FRG Wrap, Sterilization · General Hospital
Oct 2015 121d
Insta-Gard Surgical and Procedure Face Mask
K142990 · FXX Mask, Surgical · General Hospital
Mar 2015 139d
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · FXX Mask, Surgical · General Hospital
Jun 2014 149d
TIBURON SURGICAL DRAPE
K130404 · KKX Drape, Surgical · General Hospital
Jul 2013 136d
DURABLUE STERILIZATION WRAP
K130927 · FRG Wrap, Sterilization · General Hospital
Jun 2013 76d
DURABLUE STERILIZATION WRAP
K123857 · FRG Wrap, Sterilization · General Hospital
Jan 2013 40d
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION
K122507 · FRG Wrap, Sterilization · General Hospital
Sep 2012 40d
DURABLUE STERILIZATION WRAP
K120658 · FRG Wrap, Sterilization · General Hospital
Jun 2012 100d
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
K112918 · FRG Wrap, Sterilization · General Hospital
Jan 2012 109d
DURA BLUE STERILIZATION WRAP
K112211 · FRG Wrap, Sterilization · General Hospital
Oct 2011 79d
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