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
153601–153624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · BTO
Shiley, Inc.
Anesthesiology · 129d
Cleared Mar 15, 1984
RA-1000 SYS-T4(THYROXINE)SERUM ANAL
K834102 · KLI
Technicon Instruments Corp.
Chemistry · 107d
Cleared Mar 15, 1984
CHEMONUCLEOLYSIS NEEDLE
K834436 · FMI
Universal Medical Instrument Corp.
General Hospital · 87d
Cleared Mar 15, 1984
OPERATING ROOM TRAY SET
K840021 · FSM
Medi-Plast Intl., Inc.
General & Plastic Surgery · 70d
Cleared Mar 13, 1984
FCP-11ECG
K842169
Brentwood Instruments, Inc.
Cardiovascular
Cleared Mar 12, 1984
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831926 · DTG
Oscor, Inc.
Cardiovascular · 271d
Cleared Mar 12, 1984
VASCULAR RECORDER #301
K832369 · JOP
Imex Medical Systems, Inc.
Cardiovascular · 241d
Cleared Mar 12, 1984
CHYMOFAST TEST
K833418 · DHB
Allergenetics
Immunology · 161d
Cleared Mar 12, 1984
DOWNING SPECTRAL ILLUMINATOR
K833446 · HLX
Vision Health Technology
Ophthalmic · 159d
Cleared Mar 12, 1984
MATERIAL ADDITION LEXAN & K-RESIN
K833554 · DQO
Procedure Products, Inc.
Cardiovascular · 159d
Cleared Mar 12, 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 132d
Cleared Mar 12, 1984
ORTHO BACTERIURIA DETECTION SYS
K833834 · JXA
Ortho Diagnostic Systems, Inc.
Immunology · 130d
Cleared Mar 12, 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 119d
Cleared Mar 12, 1984
I/A PLUS PAK SURGICAL SYSTEM
K833961 · HQC
Ipax, Inc.
Ophthalmic · 117d
Cleared Mar 12, 1984
KPE PLUS-PAK SURGICAL SYSTEM
K833962 · HQC
Ipax, Inc.
Ophthalmic · 117d
Cleared Mar 12, 1984
NEEDLE BENDER TX8225
K834108 · LXH
Today'S Machining & Design, Inc.
Orthopedic · 104d
Cleared Mar 12, 1984
MONOJECT SOFT TISSUE BIOPSY NEEDLE
K834249 · FCG
Sherwood Medical Co.
Gastroenterology & Urology · 96d
Cleared Mar 12, 1984
PBC SCALP VEIN SET
K834255 · FOZ
Philadelphia Biologics Center
General Hospital · 96d
Cleared Mar 12, 1984
LIGACLIP METALLIC LIGATING CLIP
K834267 · FZP
Ethicon, Inc.
General & Plastic Surgery · 95d
Cleared Mar 12, 1984
PACING ELECTRODE
K834431 · DTB
Pacesetter Systems
Cardiovascular · 87d
Cleared Mar 12, 1984
FASCIA CUTTER
K834514 · GES
Stryker Corp.
General & Plastic Surgery · 82d
Cleared Mar 12, 1984
LAERDAL SUCTION UNIT
K840110 · BTA
Laerdal Medical Corp.
General & Plastic Surgery · 62d
Cleared Mar 12, 1984
MILLEREISEN CURVED BIOPSY NEEDLE
K840157 · FCG
Preventive Medicine Institute
Gastroenterology & Urology · 59d
Cleared Mar 12, 1984
WESTERMAN-JENSEN BIOPSY NEEDLE
K840168 · FCG
Popper & Sons, Inc.
Gastroenterology & Urology · 56d