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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
146521–146544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1985
PORT-GARD
K854019 · LJT
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 57d
Cleared Nov 26, 1985
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
K854024 · JHI
Corning Medical & Scientific
Chemistry · 57d
Cleared Nov 26, 1985
EXCEL BRACKET ADHESIVE
K854050 · DYH
Johnson & Johnson Professionals, Inc.
Dental · 54d
Cleared Nov 26, 1985
UNITEK LIFT-OFF DEBRACKETING INSTRUMENT
K854088 · JEX
Unitex Corp.
Dental · 50d
Cleared Nov 26, 1985
MEDSURG ULTRASOUND BIOPSY TRAY
K854289 · FCG
Medsurg Industries, Inc.
Gastroenterology & Urology · 32d
Cleared Nov 26, 1985
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY
K854291 · KNW
Medsurg Industries, Inc.
Gastroenterology & Urology · 32d
Cleared Nov 26, 1985
MEDSURG ARTHROGRAM TRAY
K854292 · LRO
Medsurg Industries, Inc.
General & Plastic Surgery · 32d
Cleared Nov 26, 1985
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM
K854297 · KNW
Medsurg Industries, Inc.
Gastroenterology & Urology · 32d
Cleared Nov 26, 1985
TECHNICON RA-500 SYSTEM
K854345 · JJC
Technicon Instruments Corp.
Chemistry · 29d
Cleared Nov 26, 1985
PLATELET-TROL II
K854353 · JPK
R&D Systems, Inc.
Hematology · 29d
Cleared Nov 26, 1985
AUTOSCAN W/A SYSTEM
K854448 · JTO
American Micro Scan
Microbiology · 21d
Cleared Nov 26, 1985
RAICHEM/K.E
K854540 · JJQ
Reagents Applications, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
CHEMSPOR
K844479 · FRC
American Sterilizer Co.
General Hospital · 371d
Cleared Nov 25, 1985
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · DDB
Kent Laboratories, Inc.
Immunology · 277d
Cleared Nov 25, 1985
OMIDERM WOUND & BURN DRESSING
K851885 · FRO
Biosystems Assoc.
General & Plastic Surgery · 209d
Cleared Nov 25, 1985
POROCOAT SYNATOMIC UNICONDYLAR KNEE
K853020 · HSX
Depuy, Inc.
Orthopedic · 130d
Cleared Nov 25, 1985
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM
K853886 · JDI
Howmedica Corp.
Orthopedic · 67d
Cleared Nov 25, 1985
EGNELL UNIVERSAL SUCTION PUMP
K853909 · BTA
Egnell, Inc.
General & Plastic Surgery · 66d
Cleared Nov 25, 1985
EGNELL COMPACT SUCTION PUMP
K853917 · BTA
Egnell, Inc.
General & Plastic Surgery · 63d
Cleared Nov 25, 1985
PLASTELAST AND/OR ELASTOPLASTE
K854006 · KGX
Cp Medical
General & Plastic Surgery · 56d
Cleared Nov 25, 1985
BIOPSY TRAY I & II
K854095 · LRO
North Coast Medi-Tek
General & Plastic Surgery · 49d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177 · CGA
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
K854178 · CGX
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179 · CHH
Clinical Data, Inc.
Chemistry · 41d