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
73–96 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 24, 2023
Quantra Hemostasis Analyzer
K230461 · QFR
Hemosonics, LLC
Hematology · 31d
Cleared Feb 15, 2023
Xpert® FII & FV
K223046 · NPR
Cepheid
Hematology · 139d
Cleared Jan 04, 2023
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
K223635 · JBP
Sienco, Inc.
Hematology · 30d
Cleared Dec 23, 2022
STA- NeoPTimal
K211485 · GJS
Diagnostica Stago S.A.S
Hematology · 589d
Cleared Dec 23, 2022
CRYOcheck Chromogenic Factor IX
K214002 · GGP
Precision Biologic, Inc.
Hematology · 367d
Cleared Dec 13, 2022
Quantra QPlus System
K223433 · QFR
Hemosonics, LLC
Hematology · 29d
Cleared Dec 09, 2022
HemosIL von Willebrand Factor Antigen
K223402 · GGP
Instrumentation Laboratory CO
Hematology · 30d
Cleared Nov 29, 2022
QStat Cartridge
K213917 · QFR
Hemosonics, LLC
Hematology · 349d
Cleared Nov 08, 2022
Sysmex XW-100 Automated Hematology Analyzer
K210346 · GKZ
Sysmex America, Inc.
Hematology · 638d
Cleared Oct 05, 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
K212779 · GJS
Coagusense, Inc.
Hematology · 399d
Cleared Oct 04, 2022
HemosIL Liquid Anti-Xa
K213464 · KFF
Instrumentation Laboratory CO
Hematology · 341d
Not Cleared Sep 29, 2022
INNOVANCE VWF Ac
DEN200067 · QTY
Siemens Healthcare Diagnostics...
Hematology · 701d
Cleared Sep 14, 2022
FINDER G6PD
K201049 · JBF
Baebies, Inc.
Hematology · 876d
Cleared Aug 16, 2022
HemosIL ReadiPlasTin
K213426 · GJS
Instrumentation Laboratory CO
Hematology · 299d
Cleared Jul 08, 2022
ROTEM sigma Thromboelastometry System
K201440 · JPA
Tem Innovations GmbH
Hematology · 767d
Cleared Jun 02, 2022
Hemosure Accu-Reader A100
K200754 · OOX
W.H.P.M., Inc.
Hematology · 801d
Cleared May 09, 2022
Sight OLO
K211840 · GKZ
S.D. Sight Diagnostics , Ltd.
Hematology · 329d
Cleared May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)...
K220013 · JOY
Scopio Labs , Ltd.
Hematology · 119d
Cleared Apr 19, 2022
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
K192931 · GKA
Helena Laboratories, Corp.
Hematology · 915d
Cleared Mar 22, 2022
Athelas Home
K200828 · GKZ
Athelas, Inc.
Hematology · 722d
Cleared Dec 29, 2021
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test...
K202101 · JPA
Accriva Diagnostics, Inc.
Hematology · 518d
Cleared Jul 02, 2021
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
K210127 · LKM
Beckman Coulter, Inc.
Hematology · 164d
Cleared Dec 18, 2020
microINR System
K201185 · GJS
Iline Microsystems, S.L.
Hematology · 231d
Cleared Nov 06, 2020
cobas u 701 microscopy analyzer
K200811 · LKM
Roche Diagnostics
Hematology · 224d