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"
433–456 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jun 02, 2022
Hemosure Accu-Reader A100
K200754 · OOX
W.H.P.M., Inc.
Hematology · 801d
Cleared May 31, 2022
Upper Arm Electronic Blood Pressure Monitor(Model...
K220113 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 137d
Cleared May 23, 2022
Assure Titanium Blood Glucose Monitoring System
K200788 · PZI
Arkray, Inc.
Chemistry · 788d
Cleared May 19, 2022
Accu-Chek Safe-T-Pro Plus Lancing Device
K220849 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 57d
Cleared May 19, 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 18, 2022
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel...
K220917 · FMK
Gri-Alleset, Inc.
General & Plastic Surgery · 49d
Cleared May 18, 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood...
K212416 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 288d
Cleared May 17, 2022
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
K220372 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 97d
Cleared May 06, 2022
IWL2020 Blood Glucose Monitoring System
K203711 · NBW
Roche Diabetes Care, Inc.
Chemistry · 501d
Cleared CT May 04, 2022
LiveOne
K201302 · DXN
Livemetric (Medical) S.A.
Cardiovascular · 719d
Cleared May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)...
K220013 · JOY
Scopio Labs , Ltd.
Hematology · 119d
Cleared Apr 29, 2022
Accu-Chek FastClix Blood Lancing System
K220608 · QRL
Roche Diabetes Care, Inc.
General & Plastic Surgery · 58d
Cleared Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K213236 · PEN
Genmark Diagnostics, Incorporated
Microbiology · 209d
Cleared Apr 20, 2022
GEM FLOW COUPLER Monitor (GEM1020M-2)
K213974 · DPW
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 121d
Cleared Apr 12, 2022
Safety Blood Collection / Infusion Set (with/without needle holder), Blood...
K214075 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 106d
Cleared Apr 06, 2022
MTM301 Blood Glucose and Ketone Monitoring System
K202534 · NBW
Apex BioTechnology Corp.
Chemistry · 582d
Cleared Apr 05, 2022
Accu-Chek Safe-T-Pro Uno Lancing Device
K220364 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 56d
Cleared Mar 30, 2022
CareTaker Monitor App
K213699 · DXN
Caretaker Medical, LLC
Cardiovascular · 127d
Cleared Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
K213887 · NBW
Apex BioTechnology Corp.
Chemistry · 106d
Cleared Mar 01, 2022
Wrist-type Fully Automatic Digital Blood Pressure Monitor
K213189 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 153d
Cleared Feb 26, 2022
CardioChek Plus Test System
K193406 · NBW
Polymer Technology Systems, Inc....
Chemistry · 810d
Cleared Feb 18, 2022
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
K213503 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 109d
Cleared Feb 17, 2022
Accu-Chek Softclix Blood Lancing System
K214022 · QRL
Roche Diabetes Care, Inc.
General & Plastic Surgery · 57d
Cleared Feb 04, 2022
BD Vacutainer UltraTouch Push Button Blood Collection Set
K212724 · JKA
Becton, Dickinson and Company
General Hospital · 161d