Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Hematology ×
3,297 results
25–48 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 02, 2025
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
K250965 · JPA
Sysmex America, Inc.
Hematology · 63d
Cleared May 30, 2025
LensHooke X3 PRO Semen Quality Analyzer
K242830 · POV
Bonraybio Co., Ltd.
Hematology · 253d
Not Cleared May 22, 2025
ConcizuTrace™ ELISA
DEN240035 · SES
Randox Laboratories, Ltd.
Hematology · 325d
Cleared May 09, 2025
LensHooke X12 PRO Semen Analysis System
K242388 · POV
Bonraybio Co., Ltd.
Hematology · 270d
Cleared May 02, 2025
SQA-iOw Sperm Quality Analyzer
K243114 · POV
Medical Electronic Systems , Ltd.
Hematology · 214d
Cleared Apr 30, 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K251024 · JPA
Haemonetics
Hematology · 28d
Cleared CT Mar 28, 2025
INNOVANCE Antithrombin
K242952 · JBQ
Siemens Healthcare Diagnostic...
Hematology · 184d
Cleared Feb 27, 2025
microINR System
K243543 · GJS
Iline Microsystems, S.L.
Hematology · 104d
Cleared Feb 21, 2025
Xpert® FII & FV
K250218 · NPR
Cepheid
Hematology · 28d
Cleared Feb 20, 2025
Alinity h-series System
K243283 · GKZ
Abbott Laboratories
Hematology · 126d
Cleared Feb 03, 2025
Cito CBC System
K240402 · GKZ
Cytochip, Inc.
Hematology · 360d
Cleared Jan 28, 2025
HemosIL CL HIT-IgG(PF4-H)
K243374 · LCO
Instrumentation Laboratory (IL) Co.
Hematology · 90d
Cleared Jan 15, 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K243858 · JPA
Haemonetics Corporation
Hematology · 30d
Cleared Nov 29, 2024
YO Home Sperm Test
K241628 · POV
Medical Electronic Systems , Ltd.
Hematology · 176d
Cleared Oct 31, 2024
BD Vacutainer® Citrate Blood Collection Tubes
K240455 · GIM
Becton, Dickinson and Company
Hematology · 259d
Cleared Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
K240315 · QLU
Siemens Healthcare Diagnostics...
Hematology · 251d
Cleared Aug 16, 2024
ACL TOP Family 50 Series (ACL TOP 750
K242127 · GKP
Instrumentation Laboratory (IL) Co.
Hematology · 28d
Cleared Jul 05, 2024
UniCel DxH 900 Coulter Cellular Analysis System
K240252 · GKZ
Beckman Coulter, Inc.
Hematology · 157d
Cleared May 21, 2024
Yumizen H2500
K232946 · GKZ
HORIBA ABX SAS
Hematology · 244d
Cleared May 02, 2024
HemoScreen Hematology Analyzer
K240636 · GKZ
Pixcell Medical Technologies
Hematology · 57d
Cleared Apr 22, 2024
Access EPO
K240182 · GGT
Beckman Coulter, Inc.
Hematology · 90d
Cleared Apr 04, 2024
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
K232027 · GKA
Sebia
Hematology · 272d
Cleared Mar 29, 2024
Citrated: K, KH, RTH, FFH
K232018 · JPA
Haemonetics Corporation
Hematology · 266d
Cleared CT Mar 27, 2024
QStat Cartridge
K240045 · QFR
Hemosonics, LLC
Hematology · 82d