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

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5,555 results for "blood"
145–168 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d
Cleared Jan 23, 2025
Vios Monitoring System(TM) Model 2050
K241728 · DXN
Murata Vios, Inc.
Cardiovascular · 223d
Cleared Jan 14, 2025
BB-613-BPM
K241066 · DXN
Biobeat Technologies , Ltd.
Cardiovascular · 271d
Cleared Jan 13, 2025
Sterilized Eol Auto Lancet
K243533 · FMK
Hlb Co., Ltd. Healthcare
General & Plastic Surgery · 59d
Cleared Jan 13, 2025
LetsGetChecked Impress
K242680 · FMK
Privapath Diagnostics Ltd (Dba...
General & Plastic Surgery · 129d
Cleared Jan 13, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L,...
K241431 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 237d
Cleared Jan 10, 2025
Safety Winged Blood Collection Sets
K243806 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 30d
Cleared Jan 10, 2025
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269,...
K242528 · DXN
Shenzhen Ruiankang Technology Co., Ltd.
Cardiovascular · 137d
Cleared Dec 20, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)...
K243759 · PEN
Biofire Diagnostics, LLC
Microbiology · 14d
Cleared Dec 20, 2024
Moda-flx Hemodialysis System™ Cartridge (102121-001 )
K243607 · FJK
Diality, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 20, 2024
KIDS Arterial Filters
K242953 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Dec 13, 2024
ABL90 FLEX PLUS System
K240998 · CHL
Radiometer Medicals Aps
Chemistry · 246d
Cleared Nov 26, 2024
Arm Blood Pressure Monitor (model: BPM-A7VL)
K243118 · DXN
Shenzhen Imdk Medical Technology Co.,...
Cardiovascular · 57d
Cleared Nov 19, 2024
XPER Technology PREMIUM Pro Blood Glucose Monitoring System
K221349 · PZI
Taidoc Technology Corporation
Chemistry · 925d
Cleared Nov 18, 2024
MICRO Arterial Filters
K242092 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 124d
Cleared Nov 15, 2024
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)
K243306 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 25d
Cleared Nov 05, 2024
gentleheel® Adult Incision Device
K242664 · FMK
Gri-Alleset, Inc.
General & Plastic Surgery · 62d
Cleared Nov 04, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · NBW
Bionime Corporation
Chemistry · 243d
Cleared Nov 01, 2024
BD Vacutainer® One Use Holder
K242320 · JKA
Becton, Dickinson and Company
General Hospital · 88d
Cleared Nov 01, 2024
SC+ Hemodialysis Device (SC-14269)
K242269 · ONW
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 92d
Cleared Oct 31, 2024
Disposable Blood Pressure cuff
K242623 · DXQ
Shenzhen Medke Technology Co., Ltd.
Cardiovascular · 58d
Cleared Oct 31, 2024
BD Vacutainer® Citrate Blood Collection Tubes
K240455 · GIM
Becton, Dickinson and Company
Hematology · 259d
Cleared Oct 30, 2024
Safety Lancet
K242627 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 57d
Cleared Oct 28, 2024
Sterile Lancets for Single Use
K242622 · QRK
Ningbo Caremed Medical Products Co.,...
General & Plastic Surgery · 55d