Cardinal Health200, LLC
Waukegan, IL, US
Cardinal Health200, LLC appears in FDA device records in Waukegan, IL. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Cardinal Health200, LLC between 2011 and 2024. The busiest year on record is 2012, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241780 | Cardinal Health Nitrile Exam Gloves | LZA | Substantially Equivalent | |
| K230838 | Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets | FYA | Substantially Equivalent | |
| K223376 | 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) | MEG | Substantially Equivalent | |
| K230028 | 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 | JOW | Substantially Equivalent | |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | KGO | Substantially Equivalent | |
| K211390 | Nitrile Blue Powder-free Examination Glove | LZA | Substantially Equivalent | |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | FYA | Substantially Equivalent | |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | FYA | Substantially Equivalent | |
| K192374 | Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip | FXX | Substantially Equivalent | |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | QPC | Substantially Equivalent | |
| K181174 | Cardinal Health Sterilization Wrap | FRG | Substantially Equivalent | |
| K170762 | Cardinal Health Non-Reinforced Surgical Gown | FYA | Substantially Equivalent | |
| K161910 | Cardinal Health Sterilization Wrap | FRG | Substantially Equivalent | |
| K160339 | Cardinal Health Isolation Gown | FYC | Substantially Equivalent | |
| K151445 | Cardinal Health Sterilization Wrap | FRG | Substantially Equivalent | |
| K151788 | Cardinal Health Sterilization Wrap | FRG | Substantially Equivalent | |
| K142990 | Insta-Gard Surgical and Procedure Face Mask | FXX | Substantially Equivalent | |
| K140155 | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK | FXX | Substantially Equivalent | |
| K130404 | TIBURON SURGICAL DRAPE | KKX | Substantially Equivalent | |
| K130927 | DURABLUE STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K123857 | DURABLUE STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K122507 | DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION | FRG | Substantially Equivalent | |
| K120658 | DURABLUE STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K112918 | DURABLUE STERILIZATION (AMSCO V-PRO) WRAP | FRG | Substantially Equivalent | |
| K112283 | DURA BLUE STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K112211 | DURA BLUE STERILIZATION WRAP | FRG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KKXDrape, Surgical, Antimicrobial
- FYCGown, Isolation, Surgical
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- FYAGown, Surgical
- FXXMask, Surgical
- LZAPolymer Patient Examination Glove
- JOWSleeve, Limb, Compressible
- KGOSurgeon'S Gloves
- MEGSyringe, Antistick
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain