FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

5,546 results for "blood"
4153–4176 of 5,546
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared May 20, 1986
BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE
K861815 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 16, 1986
DINAMAP VITAL SIGNS MONITOR MODEL 8100
K854434 · DXN
Critikon Company, LLC
Cardiovascular · 192d
Cleared May 12, 1986
MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE
K861560 · FMI
Medi Point, Inc.
General Hospital · 17d
Cleared May 12, 1986
OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901
K860196 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 110d
Cleared May 09, 1986
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731
K854797 · DXN
Takeda Medical, Inc.
Cardiovascular · 158d
Cleared May 07, 1986
TDK ECG ELECTRODE MEL-08-09 & -11
K854596 · DRS
Tdk Corp.
Cardiovascular · 170d
Cleared May 07, 1986
DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE
K853996 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 219d
Cleared May 06, 1986
EXEL VACUUM BLOOD COLLECTING SYSTEM
K861152 · FMI
Exel Intl.
General Hospital · 41d
Cleared May 06, 1986
BIOTEL (TM)/ KIDNEY
K855237 · KHE
American Diagnostic Corp.
Hematology · 126d
Cleared May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465 · CIT
Abbott Laboratories
Chemistry · 88d
Cleared May 05, 1986
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
K860435 · DPT
Multigon Industries, Inc.
Cardiovascular · 90d
Cleared Apr 30, 1986
DIALET LANCING DEVICE
K861265 · FMK
Home Diagnostics, Inc.
General & Plastic Surgery · 26d
Cleared Apr 29, 1986
NEONATAL UNILET
K861243 · FMK
Ulster Scientific, Inc.
General & Plastic Surgery · 27d
Cleared Apr 28, 1986
PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3
K860287 · DXN
Healthcheck Corp.
Cardiovascular · 90d
Cleared Apr 28, 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · DXN
Nihon Kohden America, Inc.
Cardiovascular · 181d
Cleared Apr 21, 1986
IONIZED CALCIUM AND BLOOD PH TESTCARDS
K860639 · JFP
Ilex Corp.
Chemistry · 60d
Cleared Apr 21, 1986
BLOOD UREA NITROGEN (BUN) TESTCARD
K860543 · CDS
Ilex Corp.
Chemistry · 67d
Cleared Apr 17, 1986
OMRON DIGITAL BP MONITOR HEM-700CP
K854201 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 184d
Cleared Apr 15, 1986
SUEL BLOOD LANCET
K861151 · FMK
Exel Intl.
General & Plastic Surgery · 20d
Cleared Apr 09, 1986
EZ DETECH-URINE BLOOD TEST STICKS
K854358 · KHE
Self Care Systems, Inc.
Chemistry · 162d
Cleared Apr 07, 1986
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
K860028 · KHE
Self Care Systems, Inc.
Hematology · 94d
Cleared Apr 07, 1986
MARQUEST QC-IV TONOMETER
K855024 · JJS
Marquest Medical Products, Inc.
Chemistry · 111d
Cleared Apr 04, 1986
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
K860166 · GKL
Diagnostic Technology, Inc.
Hematology · 77d
Cleared Apr 04, 1986
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
K860122 · JBP
Medical Device Consultants, Inc.
Hematology · 80d