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
166225–166248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1980
J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
K801434 · DDG
J.T. Baker Chemical Co.
Immunology · 20d
Cleared Jul 08, 1980
APPLICATION OF EMIT AED ASSAYS
K801475 · KLI
Syva Co.
Toxicology · 14d
Cleared Jul 08, 1980
APPLICATION OF EMIT THEOPHYLLINE ASSAY
K801476 · KLS
Syva Co.
Toxicology · 14d
Cleared Jul 08, 1980
SERIES 602 CKG RECORDER (MODIFIED)
K801485 · DSF
Cardio Kinetics, Inc.
Cardiovascular · 14d
Cleared Jul 08, 1980
ABBY II PATIENT MONITOR OR VITAL SIGNS M
K801515 · DRT
Abbott Medical Electronics Co.
Cardiovascular · 8d
Cleared Jun 30, 1980
RUBELLA BIO-BEAD TITRATION KIT
K800789 · GOL
Litton Bionetics
Microbiology · 83d
Cleared Jun 30, 1980
PERMANENT & TEMP. PACEMAKER ELECTRODE
K800795 · DTB
Daig Corp.
Cardiovascular · 82d
Cleared Jun 30, 1980
SIEMENS-ELECTROGERATE GMBH MICRO-INHALER
K800830 · CAF
Macbeth Sales Corp.
Radiology · 77d
Cleared Jun 30, 1980
SER-TEX
K800834 · KOH
V.S.S.I., Inc.
Obstetrics & Gynecology · 77d
Cleared Jun 30, 1980
PROGRAMMABLE BIPOLAR CARDIAC GENERATOR
K800837 · DXY
Arco Medical Products Co.
Cardiovascular · 76d
Cleared Jun 30, 1980
GE LEAD ADAPTER, MODEL 345-01
K801040 · DTD
Intermedics, Inc.
Cardiovascular · 59d
Cleared Jun 30, 1980
GF120H DIALYZER
K801045 · FJI
Gambro, Inc.
Gastroenterology & Urology · 56d
Cleared Jun 30, 1980
WAKO PHOSPHOLIPIDS TEST
K801076 · CEL
Wako Pure Chemical Industries, Ltd.
Chemistry · 54d
Cleared Jun 30, 1980
MICROTHIN-P1 (MOD. 0622)
K801121 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1980
MICROTHIN-D1 (MOD. 0620)
K801122 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1980
QUICKTAN BOOTH
K801129
Quicktan Mfg.
Radiology · 49d
Cleared Jun 30, 1980
BEL O SOL UVA SUNLAMP DEVICE
K801149
Hopeful Sunlamp Corp.
Radiology · 48d
Cleared Jun 30, 1980
CO2 LASER
K801197 · HHR
Advanced Biomedical Instruments
Obstetrics & Gynecology · 42d
Cleared Jun 30, 1980
UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.
K801241 · DXY
Arco Medical Products Co.
Cardiovascular · 34d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA
K801282 · DFT
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
K801283 · CZP
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Jun 30, 1980
EMIT AAII THYROXINE CALIBRATORS
K801287 · JIS
Syva Co.
Chemistry · 31d
Cleared Jun 30, 1980
EMIT AAII THYROXINE ASSAY
K801288 · KLI
Syva Co.
Chemistry · 31d
Cleared Jun 30, 1980
LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT
K801289 · LCP
Leeco Diagnostics, Inc.
Hematology · 31d