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

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175,820 results
150865–150888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1984
SANDARE ALKALINE PHOSPHATASE PROCEDURE
K844498 · CIO
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared Dec 07, 1984
REPLACE-A-TIP ADJUST. LOW TEMP.-
K841459 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 242d
Cleared Dec 07, 1984
REPLACE-A-TIP ADJUSTABLE HIGH TEMP.
K841509 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 240d
Cleared Dec 07, 1984
ADJUST-A-TEMP MICRO
K841603 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 232d
Cleared Dec 07, 1984
ADJUST-A-TEMP HIGH TEMPERATURE
K841604 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 232d
Cleared Dec 07, 1984
PERCUTANEOUS GASTROSTOMY TUBE
K842174 · KNT
Mount Carmel Mercy Hospital
Gastroenterology & Urology · 184d
Cleared Dec 07, 1984
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370 · DXH
Hewlett-Packard Co.
Cardiovascular · 175d
Cleared Dec 07, 1984
ACU-PATCH
K842946 · KGX
Acutek
General & Plastic Surgery · 134d
Cleared Dec 07, 1984
MC-4000 CONSOLE & PROBES
K842959 · GEH
Cryomedics, Inc.
General & Plastic Surgery · 133d
Cleared Dec 07, 1984
TOP HYPODERMIC SYRINGE LUER LOCK
K843415 · FMF
Top Surgical Manufacturers Co.
General Hospital · 98d
Cleared Dec 07, 1984
MINUTEMAN CO2 MICROSURG LASER DERMATOL-
K843517 · GEY
American Surgical Laser, Inc.
General & Plastic Surgery · 93d
Cleared Dec 07, 1984
MINUTEMAN C02 MICROSURG LASER PODIATRY
K843518 · GEY
American Surgical Laser, Inc.
General & Plastic Surgery · 93d
Cleared Dec 07, 1984
MINUTEMAN CO2 MICROSURG LASER GEN SURG
K843519 · GEY
American Surgical Laser, Inc.
General & Plastic Surgery · 93d
Cleared Dec 07, 1984
IV JET
K843887 · FMF
Nuclear Concepts, Inc.
General Hospital · 66d
Cleared Dec 07, 1984
TOSHIBA DIGITAL CLINICAL THERMOMETER
K844124 · FLL
Toshiba Medical Systems
General Hospital · 45d
Cleared Dec 07, 1984
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
K844174 · KNT
Exco, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 06, 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
K843129 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 119d
Cleared Dec 06, 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4
K843130 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 119d
Cleared Dec 06, 1984
KETAC-SILVER
K843566 · EMA
Espe GmbH (Us)
Dental · 87d
Cleared Dec 06, 1984
CADD-1 5100 AMBULATORY INFUSION PUMP
K843772 · FRN
Deltec Systems, Inc.
General Hospital · 72d
Cleared Dec 06, 1984
CADD-PAC 5200 AMBULATORY INFUSION PUMP
K843773 · FRN
Deltec Systems, Inc.
General Hospital · 72d
Cleared Dec 06, 1984
HEPARIN INFUSIN PUMP
K843878 · FRN
Armament Systems, Inc.
General Hospital · 65d
Cleared Dec 06, 1984
FOCUSCOPE UNIVERSAL SYSTEM
K843900 · GDB
Medical Diagnostics, Ca.
Gastroenterology & Urology · 64d
Cleared Dec 06, 1984
FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
K844105
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 44d