Cleared 510(k) Submissions with Supporting Documents - 2022
This list includes cleared 510(k) submissions for 2022 for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.
The clearances are listed by clearance date in reverse chronological order.
510(k) Number | Applicant | Device Name | Decision Date |
---|---|---|---|
BK220750 | THIEBAUD SAS
Paris, France |
st’rim, macro st'rim, mini st’rim and nano st’rim | 8/26/2022 |
BK210658 | Terumo BCT, Inc.
Lakewood, CO 80215 |
IMUGARD® WB PLT Platelet Pooling Set | 8/26/2022 |
BK220670 | Immucor, Inc.
Norcross, GA |
Galileo NEO® | 7/26/2022 |
BK220669 | Immucor, Inc.
Norcross, GA |
NEO Iris® | 7/26/2022 |
BK210584 | GenesisBPS, LLC
Ramsey, NJ |
Genesis RapidWeld II STW, model GRW-430-02 | 7/15/2022 |
BK210661 | RegenLab SA
Avon, Minnesota |
RegenKit-Wound Gel-2 | 7/8/2022 |
BK220724 | Ortho-Clinical Diagnostics, Inc.
Raritan, NJ |
ORTHO Optix™ Reader | 6/24/2022 |
BK210653 | Millipore (UK) Ltd.
United Kingdom |
ORTHO™ Daily QC Simulated Whole Blood Quality Control Kit | 6/7/2022 |
BK210631 | Sysmex America, Inc.
Lincolnshire, IL |
Sysmex XN-10 Automated Hematology Analyzer | 5/23/2022 |
BK200540 | Arteriocyte Medical Systems, Inc.
Hopkinton, MA |
Precise Cell Concentration System | 3/17/2022 |
BK220674 | MicroAire Surgical Instruments, LLC.
Charlottesville, VA |
MicroAire LipoFilter® System | 3/16/2022 |
BK210635 | Terumo BCT, Inc.
Lakewood, CO |
Rika Plasma Donation System; Rika Plasma Separation Set; Rika Plasma Bottle | 3/7/2022 |
BK210625 | Bio-Rad Medical Diagnostics GmbH
Dreieich, Germany |
IH-500 | 2/28/2022 |
BK210632 | Royal Biologics, Inc.
Hackensack, NJ |
Royal MAXX PRP Concentration System | 2/11/2022 |
BK210591 | Terumo BCT, Inc
Lakewood, CO |
Platelet-Rich Plasma (PRP) Procedure Pack | 2/11/2022 |
BK210652 | Becton, Dickinson and Company
San Jose, CA |
BD® Stem Cell Enumeration Kit | 1/27/2022 |
BK210650 | CSL Plasma
Knoxville, TN |
LOGIC 4.0.8 | 1/25/2022 |
BK210649 | Becton, Dickinson & Company
Franklin Lakes, NJ |
BD Vacutainer ACD A Blood Collection Tube; BD Vacutainer ACD B Blood Collection Tube | 1/21/2022 |