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

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176,076 results
154441–154464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1984
ENDO-SECURE
K840844 · JAY
Exidyne, Inc.
Anesthesiology · 21d
Cleared Mar 16, 1984
OXYGEN TUBING
K840897 · CAT
Medical Technologies of Georgia
Anesthesiology · 18d
Cleared Mar 16, 1984
PALL COALESCER
K840960 · CAH
Pall Biomedical Products Co.
General Hospital · 10d
Cleared Mar 15, 1984
BIO-BAND BANDAGES
K822306 · FRO
Robert Hirschfield
General & Plastic Surgery · 594d
Cleared Mar 15, 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
K833465 · HQC
CooperVision, Inc.
Ophthalmic · 162d
Cleared Mar 15, 1984
TITAN GEL LIPOPROTEIN ELECTROPHORESIS
K833611 · JHO
Helena Laboratories
Chemistry · 154d
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