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
169873–169896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1979
CATHETER, OXYGEN
K790057 · BZB
Medline Industries, Inc.
Anesthesiology · 27d
Cleared Feb 05, 1979
DRILL, CORDLESS SURGICAL
K790063 · KIJ
Richard'S Medical Equip., Inc.
Orthopedic · 21d
Cleared Feb 02, 1979
FLEXT-THERM
K781916 · KXZ
E-Z-Em, Inc.
Radiology · 80d
Cleared Feb 01, 1979
VERTETRAC
K771988 · HST
Ballert Orthopedic Corp.
Neurology · 470d
Cleared Feb 01, 1979
LIFELINE PACING LEAD MODEL 465-01
K781497 · DTB
Intermedics, Inc.
Cardiovascular · 155d
Cleared Feb 01, 1979
LIFELINE BIPOLAR PACING LEAD MOD. 466-01
K781498 · DTB
Intermedics, Inc.
Cardiovascular · 155d
Cleared Feb 01, 1979
LIFELINE PACING LEAD MODEL 467-01
K781499 · DTB
Intermedics, Inc.
Cardiovascular · 155d
Cleared Feb 01, 1979
ENDOCARIDAL PACING LEAD UNIPOLAR 477
K781525 · DTB
Intermedics, Inc.
Cardiovascular · 149d
Cleared Feb 01, 1979
SUTURELESS MUOCARDINE PACING LEADS 471
K781570 · DTB
Intermedics, Inc.
Cardiovascular · 140d
Cleared Feb 01, 1979
PANT LINER, DISP. INCONTINENT
K781930 · EYQ
Fibre Formations, Inc.
Gastroenterology & Urology · 78d
Cleared Feb 01, 1979
RIA KIT, IMMO PHASE
K781953 · JLW
Corning Medical & Scientific
Chemistry · 72d
Cleared Feb 01, 1979
A-GENT CK-MB
K782015 · JHW
Abbott Laboratories
Chemistry · 58d
Cleared Feb 01, 1979
REAGENT, COCCI LATEX
K782070 · GMG
I M, Inc.
Microbiology · 51d
Cleared Feb 01, 1979
ELECTRODE SYSTEM, QUIK-PREP
K782079 · DRX
Quinton, Inc.
Cardiovascular · 50d
Cleared Feb 01, 1979
EMIT THYROXINE ASSAY
K782085 · KLI
Syva Co.
Chemistry · 49d
Cleared Feb 01, 1979
AM-PEN SCREEN
K782086 · JTO
Pfizer, Inc.
Microbiology · 49d
Cleared Feb 01, 1979
ASTRA-VAC
K782115 · GCY
Ab Astra
General & Plastic Surgery · 36d
Cleared Feb 01, 1979
MARTIN-LEWIS MEDIUM
K782117 · JTY
Prepared Media Laboratory, Inc.
Microbiology · 36d
Cleared Feb 01, 1979
DIAGNOSTIC KIT, FERRITAB-FE-59
K782159 · JJA
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Feb 01, 1979
PREGNANCY TEST KIT, DAISY 2 IN HOME
K790002 · JHJ
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Feb 01, 1979
MANIFOLD, DISPOSABLE 3 VALVE
K790010 · FMG
Cordis Corp.
General Hospital · 30d
Cleared Feb 01, 1979
SERUM, POTASSIUM DETERMINATION OF
K790018 · CEM
Fisher Scientific Co., LLC
Chemistry · 29d
Cleared Feb 01, 1979
DISPOSABLE VACUUM CURETTE
K790032 · HCY
British Marketing Ent., Ltd.
Obstetrics & Gynecology · 29d
Cleared Feb 01, 1979
INTRODUCERS
K790034 · DYB
Clincal Instruments Corp.
Cardiovascular · 29d