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

Filters: Cleared only ×
175,230 results
164281–164304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1981
URISTOP
K803109
The Sora Co.
Gastroenterology & Urology · 77d
Cleared Feb 25, 1981
CORDIA A
K810046 · KHW
Cordis Corp.
Immunology · 44d
Cleared Feb 25, 1981
GAMBRO BICARBONATE MODULE, BCM-10
K810127 · FKR
Gambro, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 25, 1981
VC 430 VIDEO CONVERTER
K810164 · DXJ
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
DUAL TRACE VIDEO MONITOR VM 410
K810165 · DXJ
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
1,2,3 CHANNELL RECORDERS (AR150,AR250,-)
K810166 · DSF
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
SINGLE CHANNELL RECORDER AR110
K810167 · DSF
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
SLAVE MONITORS DC109 & VS109
K810168 · DXJ
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
CENTRAL STATION CONTROLLER AC100/CE100
K810169 · DSF
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
TREND GRAPH FUNCTION BLOCK
K810170 · DXG
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · DSK
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PRESSURE FUNCTION BLOCKS
K810172 · DSK
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
ECG FUNCTION BLOCK
K810176 · DPS
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PATIENT MONITOR MODEL CM130, 140
K810177 · DXG
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PATIENT MONITOR CM111, 112
K810178 · DSK
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
DUAL TRACE PATIENT MONITOR 116,118,120
K810179 · DSK
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION
K810183 · IZI
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared Feb 25, 1981
WALL CASSETTE HOLDER - TRAC44
K810194 · IXY
Philips Medical Systems (Cleveland),...
Radiology · 33d
Cleared Feb 25, 1981
BIO CARE OXYGEN CONCENTRATOR
K810272 · CAW
The Biomed Group
Anesthesiology · 23d
Cleared Feb 25, 1981
UROLOGICAL CATHETERS
K810281 · KOD
Latex Ind., Inc.
Gastroenterology & Urology · 23d
Cleared Feb 25, 1981
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · DHN
Immuno Concepts, Inc.
Immunology · 21d
Cleared Feb 25, 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · CEP
Bio-Rad
Chemistry · 20d
Cleared Feb 25, 1981
MODEL LC-85 UV DETECTOR
K810304 · LDM
The Perkin-Elmer Corp.
Toxicology · 20d
Cleared Feb 25, 1981
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · JJJ
Beckman Instruments, Inc.
Chemistry · 15d