Company · US
Cardinal Health 200, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2026. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (1 in 12 months)
303recalls (30 in 12 months)
90recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GBX | Catheter, Irrigation | 53 |
| FMI | Needle, Hypodermic, Single Lumen | 23 |
| KGO | Surgeon'S Gloves | 18 |
| FMF | Syringe, Piston | 17 |
| OEA | Non-Surgical Gown | 13 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 11 |
| PUI | Drape, Surgical, Exempt | 10 |
| LRO | General Surgery Tray | 9 |
| LRP | Tray, Surgical | 9 |
| IME | Pack, Hot Or Cold, Reusable | 8 |
| FOS | Catheter, Umbilical Artery | 7 |
| LYU | Accessory, Surgical Apparel | 6 |
| OEZ | Cardiovascular Procedure Kit | 6 |
| OJG | Neurological Tray | 6 |
| FLL | Continuous Measurement Thermometer | 5 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 5 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 5 |
| OGR | Ear, Nose, And Throat Surgical Tray | 5 |
| OJH | Orthopedic Tray | 5 |
| FYA | Gown, Surgical | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2026 | K253243 | Cardinal Health Poly Reinforced Surgical Gown Cardinal Health 200, LLC | FYA |
| Mar 24, 2016 | K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating Cardinal Health 200, Inc. | KGO |
| May 21, 2015 | K150151 | SmartGownTM surgical gown Cardinal Health 200, Inc. | FYA |
| Jun 5, 2006 | K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N Cardinal Health 200, Inc. | FYA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | Cardinal Health 200, LLC Presource Packs containing Medtronic Microstream Components:
Intubation Kit
Catalog Numbers
AN23366084
AN23366085
AN2336608H
AN2336608J
Intubating Bag Kit
Catalog Number OMSVM4166A
Intubation UH K Open, Classified |
LRP | None listed |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT, LAVH , Catalog Number: PB63VHSTC Open, Classified |
OJF | None listed |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC;
2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1;
3) Open, Classified |
OHD | None listed |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU;
2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV;
3) KI Open, Classified |
NWU | None listed |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC;
2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD;
3) KI Open, Classified |
LRO | None listed |
| Sep 22, 2026 | Cardinal Health 200, LLC Presource Convenience Kits:
1) KIT, USGPIV , Catalog Number: PVMHIVMHD;
2) KIT, USGPIV , Catalog Number: PVMHIVM14;
3) KIT, USGPIV , Catalog Num Open, Classified |
OWL | None listed |
| Sep 22, 2026 | Cardinal Health 200, LLC Presource Convenience Kits:
1) KIT, PRE OP , Catalog Number: AMN548616A;
2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B;
3) KIT, PRE PROCEDURE , Catalog N Open, Classified |
LRP | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP;
2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: Open, Classified |
OJH | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM;
2) KIT, ORP MAJOR SPINE , Catalog Number: Open, Classified |
OJG | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ;
2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II Open, Classified |
OJF | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3;
2) KIT, ROBOTIC HYST , Catalog Number: Open, Classified |
OHM | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28;
2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: Open, Classified |
OHD | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX;
2) KIT, ENT HARVEST , Catalog Number: Open, Classified |
OGR | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D Open, Classified |
OFX | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540;
2) KIT, GVI OPEN HEART A B , Catalog Number: Open, Classified |
OEZ | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD;
2) KIT, EAS ROBOTIC , Catalog Number: Open, Classified |
NWU | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231 Open, Classified |
LRP | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD;
2) KIT, GYN ROBOT ACCESSORY , Catalog Number: Open, Classified |
LRO | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17 Open, Classified |
FDE | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) BASIC PACK , Catalog Number: SBA73BPGCA;
2) SPINE PACK , Catalog Number: SNE11SPHKC;
3) SPINE PACK , Catal Open, Classified |
OJK | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD;
2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4;
3) KIT,CHP BASIC NEURO , Catalog Open, Classified |
OJH | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27;
2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28;
3) CHI STD NEURO CRANI OPT 2 , Catal Open, Classified |
OJG | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF;
2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE;
3) NEURO MAJOR 2 PACK , Catal Open, Classified |
OJA | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) ENT TRAY , Catalog Number: 24-0726A;
2) KIT,SINUS , Catalog Number: PE13SPAJA;
3) KIT,SINUS , Catalog Open, Classified |
OGR | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB Open, Classified |
OEZ | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC Open, Classified |
OFQ | None listed |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B;
2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C;
3) KIT,BOSC MICROLARYNGOSCOPY , Catalog N Open, Classified |
LRO | None listed |
| Apr 2, 2026 | Cardinal Health 200, LLC Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 Open, Classified |
FMF | K851090 |
| Jan 28, 2026 | Cardinal Health 200, LLC Chest Drainage Units and Accessories:
Product Code Description
1. 8888571562 Cardinal Health Sentinel Seal CDU
2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain
3. 8888571489 Cardinal Heal Open, Classified |
GCX | None listed |
| Dec 11, 2025 | Cardinal Health 200, LLC ChemoPlus gowns:
Product Code Product Description
CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile;
CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Open, Classified |
FYA | K193327 |
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm
1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm
1 Open, Classified |
FEG | None listed |
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm)
266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Val Open, Classified |
KNT | K880850 |
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
266197 Salem Sump" Anti-Reflux Valve CE Marked
8888266197 Salem Sump" Anti-Reflux Valve Open, Classified |
KNT | K851444 |
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm)
8888265116 Salem Sump Silicone Dual Lumen Stom Open, Classified |
KNT | K830710 |
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm)
264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm)
264960 Salem Sump" Stoma Open, Classified |
KNT | K810156 |
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN
8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN
8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN Open, Classified |
FEG | K190923 |
| Jun 6, 2025 | Cardinal Health 200, LLC Kendall SCD Blended Comfort
Sleeves Knee Length Small -
For use with Kendall SCD
SmartFlow
SKU 84021B
Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Completed |
JOW | K230028 |
| Jun 6, 2025 | Cardinal Health 200, LLC Kendall SCD Comfort Sleeves
Knee Length Small, Pediatric -
For use with Kendall SCD
SmartFlow, SKU 84021P
Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Completed |
JOW | K230028 |
| Jun 6, 2025 | Cardinal Health 200, LLC SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Completed |
JOW | K230028 |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen Open, Classified |
FOS | K951738 |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen Open, Classified |
FOS | K941814 |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen Open, Classified |
FOS | K130725 |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen Open, Classified |
FOS | K130725 |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen Open, Classified |
FOS | K130725 |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs Open, Classified |
FOS | K951737 |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) ACDF PACK, Catalog Number: SNEHBACSCA;
2) ACDF PACK, Catalog Number: SNEHBACSCB Open, Classified |
PVP | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA;
2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB
3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Nu Open, Classified |
OJK | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11;
2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12
3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13
4) CHI S Open, Classified |
OJH | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12;
2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13
3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 Open, Classified |
OJG | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA;
2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB
3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC Open, Classified |
OJF | None listed |
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