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
123217–123240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1990
VLS 5300 300W XENON LIGHT SOURCE
K904681 · HBI
Vistek Corp.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
VISTEK ELECTRONIC CONTROLLER
K904682 · GEY
Vistek Corp.
General & Plastic Surgery · 64d
Cleared Dec 18, 1990
LYTENING TM 6/R
K904726 · JFP
Amdev, Inc.
Chemistry · 62d
Cleared Dec 18, 1990
CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL
K904781 · JJY
Cholestrech Corp.
Chemistry · 57d
Cleared Dec 18, 1990
CHOLESTECH L.D.X. LEVEL 1 CONTROL
K904784 · JJY
Cholestech Corp.
Chemistry · 57d
Cleared Dec 18, 1990
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820 · CDP
Immunotech Corp.
Immunology · 55d
Cleared Dec 18, 1990
DIGITCARE I.V. START KIT
K905009 · FOZ
Digitcare Corp.
General Hospital · 41d
Cleared Dec 18, 1990
ELEGANCE TSH ELISA
K905099 · JLW
Bioclone Australia Pty , Ltd.
Chemistry · 35d
Cleared Dec 17, 1990
WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER
K892671 · DQO
Wilson Biomedical, Inc.
Cardiovascular · 615d
Cleared Dec 17, 1990
MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)
K900731 · LWM
Medical Consultants Intl. , Ltd.
Dental · 305d
Cleared Dec 17, 1990
CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS
K900814 · DQK
Intellimetrics Instrument Corp.
Cardiovascular · 299d
Cleared Dec 17, 1990
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · KFM
3M Company
Cardiovascular · 201d
Cleared Dec 17, 1990
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
K902437 · DTP
Cobe Laboratories, Inc.
Cardiovascular · 196d
Cleared Dec 17, 1990
COBE ICU CONVERSION KIT
K902631 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 186d
Cleared Dec 17, 1990
COMFORTRON II (TENS)
K902948 · LWM
M. D. Products
Dental · 165d
Cleared Dec 17, 1990
SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
K902969 · DZE
Core-Vent Corp.
Dental · 164d
Cleared Dec 17, 1990
LUPO-TEST REAGENT
K903037 · GIR
Gradipore , Ltd.
Hematology · 159d
Cleared Dec 17, 1990
HASSON STABILIZING ACCESS CANNULA
K903078 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 158d
Cleared Dec 17, 1990
HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
K903199 · DQO
Medex, Inc.
Cardiovascular · 150d
Cleared Dec 17, 1990
MAXI-FLOW INSUFFLATOR TUBING SET
K903208 · HES
Adler Instrument Co.
Obstetrics & Gynecology · 150d
Cleared Dec 17, 1990
YOUNG PROPHY SYSTEM, PS UNIT
K903284 · KOJ
Young Dental Manufacturing Co. 1, LLC
Dental · 148d
Cleared Dec 17, 1990
ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER
K903481 · EBF
Dental Foremost
Dental · 137d
Cleared Dec 17, 1990
MONITRODE
K903491 · DRX
Lleventon
Cardiovascular · 136d
Cleared Dec 17, 1990
SALTER LABS MODEL #1015
K903539 · CBH
Salter Labs
Anesthesiology · 132d