FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,530 results for "blood"
409–432 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
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 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
Cleared Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
K212341 · DTZ
Qura S.R.L
Cardiovascular · 184d