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
49–72 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Not Cleared Mar 22, 2024
X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with...
DEN230034 · SAL
Scopio Labs , Ltd.
Hematology · 329d
Cleared Mar 15, 2024
Xprecia Prime Coagulation System
K230802 · GJS
Universal Biosensors Pty, Ltd.
Hematology · 358d
Not Cleared Feb 28, 2024
Technozym ADAMTS13 Activity
DEN230024 · SAC
Technoclone Herstellung Von...
Hematology · 328d
Cleared Dec 29, 2023
ACL TOP 970 CL
K233790 · JPA
Instrumentation Laboratory
Hematology · 31d
Cleared Dec 21, 2023
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
K230887 · GKZ
Sysmex America, Inc.
Hematology · 265d
Cleared Dec 13, 2023
HemosIL Chromogenic Factor IX
K230852 · GGP
Instrumentation Laboratory Company
Hematology · 260d
Cleared Nov 27, 2023
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary...
K230493 · GIM
Becton, Dickinson and Company
Hematology · 277d
Cleared Nov 14, 2023
QScout Lab
K230878 · GKZ
Ad Astra Diagnostics, Inc.
Hematology · 229d
Cleared Sep 29, 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2...
K221359 · JPA
Instrumentation Laboratory CO
Hematology · 506d
Cleared Sep 29, 2023
AnemoCheck Home
K221508 · KHG
Sanguina, Inc.
Hematology · 493d
Cleared Sep 19, 2023
AI100 with Shonit
K221309 · JOY
Sigtuple Technologies Pvt. , Ltd.
Hematology · 502d
Cleared Sep 13, 2023
CRYOcheck Factor VIII Deficient Plasma with VWF
K222831 · GJT
Precision Biologic, Inc.
Hematology · 359d
Cleared Aug 25, 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood...
K213670 · GIM
Becton, Dickinson and Company
Hematology · 641d
Cleared Aug 24, 2023
Quantra Hemostasis Analyzer
K232215 · QFR
Hemosonics, LLC
Hematology · 29d
Cleared Aug 16, 2023
HemoScreen Hematology Analyzer
K222148 · GKZ
Pixcell Medical Technologies, Ltd.
Hematology · 392d
Cleared Aug 07, 2023
SQA-iO Sperm Quality Analyzer
K220828 · POV
Medical Electronic Systems , Ltd.
Hematology · 503d
Cleared Aug 04, 2023
Alinity h-series System
K220031 · GKZ
Abbott Laboratories
Hematology · 576d
Cleared Aug 04, 2023
Premier Resolution System
K222635 · GKA
Trinity Biotech (Primus Corporation,...
Hematology · 338d
Cleared Jul 14, 2023
i-STAT PTplus Cartridge with the i-STAT 1 System
K220282 · GJS
Abbott Laboratories
Hematology · 528d
Cleared Jul 11, 2023
microINR System
K231711 · GJS
Iline Microsystems, S.L.
Hematology · 29d
Cleared Jun 23, 2023
HemosIL Liquid Anti-Xa
K223187 · QLU
Instrumentation Laboratory CO
Hematology · 254d
Cleared Jun 21, 2023
ACL TOP Family 70 Series
K231031 · GKP
Instrumentation Laboratory Company
Hematology · 71d
Cleared Jun 07, 2023
STA R Max 3, STA Compact Max 3
K212183 · JPA
Diagnostica Stago S.A.S
Hematology · 694d
Cleared Jun 02, 2023
vWF Ag
K220728 · GGP
Siemens Healthcare Diagnostics...
Hematology · 445d