FDA 510(k) Applications Submitted by JENNIFER MASON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220365 |
02/08/2022 |
Gemini Sterilization Wrap |
Medline Industries, LP |
| K210482 |
02/19/2021 |
Medline UNITE REFLEX Nitinol Staple System |
Medline Industries, Inc. |
| K220511 |
02/22/2022 |
Medline UNITE IM Fibula Implant |
Medline Industries, LP |
| K170782 |
03/15/2017 |
Medline UNITE« Snap-Off Screws |
Medline Industries, Inc. |
| K150698 |
03/18/2015 |
Gemini Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
| K040841 |
04/01/2004 |
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
MEDLINE INDUSTRIES, INC. |
| K151235 |
05/11/2015 |
Medline Foot Plates and Screws |
MEDLINE INDUSTRIES, INC. |
| K221360 |
05/11/2022 |
Medline UNITE« Medial Malleolus Peg Plate System |
Medline Industries, LP |
| K201319 |
05/18/2020 |
Medline UNITE Jones Fracture Screw System |
Medline Industires, Inc. |
| K051378 |
05/26/2005 |
POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
MEDLINE |
| K211612 |
05/26/2021 |
Medline UNITE REFLEX Dynamic Discs |
Medline Industries, Inc. |
| K161473 |
05/27/2016 |
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) |
MEDLINE, INDUSTRIES, INC. |
| K211944 |
06/23/2021 |
Medline UNITE« Digital Fusion Screw System |
Medline Industries, Inc. |
| K231885 |
06/27/2023 |
Medline UNITE« REFLEX« Nitinol Staple System |
Medline Industries, LP |
| K151754 |
06/29/2015 |
Glide-On Vinyl Examination Gloves |
MEDLINE INDUSTRIES, INC. |
| K201829 |
07/02/2020 |
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
| K181820 |
07/09/2018 |
Medline Unite Mini Plates and Screws |
Medline Industries, Inc. |
| K191915 |
07/17/2019 |
SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V |
Medline Industries, Inc |
| K152428 |
08/26/2015 |
SensiCare PI Surgical Gloves |
MEDLINE INDUSTRIES, INC. |
| K202449 |
08/26/2020 |
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm▓ per glove of Extractable Protein |
Medline Industries, Inc. |
| K222665 |
09/06/2022 |
Medline UNITE« Ankle Fusion Plating System |
Medline Industries, Inc. |
| K152564 |
09/09/2015 |
Gemini Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
| K212911 |
09/13/2021 |
Konig Mogen Clamp |
Medline Industries, Inc |
| K202668 |
09/14/2020 |
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm2 per Glove of Extractable Protein |
Medline Industries, Inc. |
| K192641 |
09/24/2019 |
Gemini Titan Sterilization Wrap |
Medline Industries, Inc. |
| K052833 |
10/06/2005 |
GORE-TEX NON-STERILE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
| K162829 |
10/07/2016 |
Medline UNITE« Ankle Fracture Plating System |
MEDLINE, INDUSTRIES, INC. |
| K192988 |
10/25/2019 |
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use |
Medline Industries, Inc. |
| K162982 |
10/26/2016 |
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
| K162993 |
10/27/2016 |
Gemini Sterilization Wrap |
Medline Industries, Inc. |
| K213567 |
11/09/2021 |
Medline UNITE Calcaneal Fracture Plating System |
Medline Industries, LP |
| K143322 |
11/19/2014 |
Medline Natural Lubricating Liquid |
MEDLINE INDUSTRIES, INC. |
| K193217 |
11/21/2019 |
SensiCare PI and SensiCare PI Micro Surgical Gloves |
Medline Industries, Inc. |
| K203538 |
12/03/2020 |
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
| K143529 |
12/12/2014 |
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer |
MEDLINE INDUSTRIES, INC. |
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