Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
167065–167088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1980
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
K801384 · GZB
Medtronic Vascular
Neurology · 27d
Cleared Jul 08, 1980
AMERLEX DIGOXIN RIA KIT
K801413 · LCS
Amersham Corp.
Toxicology · 22d
Cleared Jul 08, 1980
SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.
K801422 · LCP
Sandare Chemical Co., Inc.
Hematology · 21d
Cleared Jul 08, 1980
CONTROL SYRINGE
K801430 · FMF
Abco Dealers, Inc.
General Hospital · 21d
Cleared Jul 08, 1980
HEMOPEXIN NEPHELOMETRIC ASSAY
K801432 · CZX
J.T. Baker Chemical Co.
Immunology · 20d
Cleared Jul 08, 1980
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K801433 · DAD
J.T. Baker Chemical Co.
Immunology · 20d
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