FDA 510(k) Applications Submitted by CAITLIN SENTER, MS, RAC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150266 |
02/04/2015 |
Remington Medical Inc. Tuohy Epidural Needles |
REMINGTON MEDICAL, INC. |
| K191315 |
05/15/2019 |
Remington Medical, Inc. Automatic Cutting Needle (NAC) |
Remington Medical, Inc. |
| K211589 |
05/24/2021 |
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger |
Remington Medical, Inc. |
| K231938 |
06/30/2023 |
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for |
O&M Halyard, Inc. |
| K241909 |
07/01/2024 |
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
O&M Halyard, Inc. |
| K212065 |
07/02/2021 |
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger |
Remington Medical, Inc. |
| K242558 |
08/28/2024 |
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
O&M Halyard, Inc. |
| K232777 |
09/11/2023 |
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) |
Owens & Minor (O&M) Halyard, Inc. |
| K232824 |
09/13/2023 |
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOF |
Owens & Minor (O&M) Halyard, Inc. |
| K243172 |
09/30/2024 |
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles |
O&M Halyard, Inc. |
| K102923 |
10/01/2010 |
BARRIER N95 PARTICULATE RESPIRATOR |
MOLNLYCKE HEALTHCARE |
| K130282 |
02/05/2013 |
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT |
REMINGTON MEDICAL, INC. |
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