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
168457–168480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1980
RENAL SYSTEMS HEMODIALYSIS CONCENTRATE
K792213 · KPO
Renal Systems, Inc.
Gastroenterology & Urology · 63d
Cleared Jan 04, 1980
TEETH, DENTURE, PLASTIC
K792245 · ELM
Dentsply Intl.
Dental · 58d
Cleared Jan 04, 1980
CMS 6000
K792380 · GYE
Physio-Control Corp.
Neurology · 39d
Cleared Jan 04, 1980
OPERATING TABLES & AMPLINOX 03
K792569 · BWN
Ets Rene Marzet
General & Plastic Surgery · 22d
Cleared Jan 04, 1980
ENDOVAGE SYRINGE
K792577 · EIC
Dental Development Services, Inc.
Dental · 21d
Cleared Jan 04, 1980
EPIC CANNULA
K792578 · EIC
Dental Development Services, Inc.
Dental · 21d
Cleared Jan 04, 1980
AP-1 AUTO PROGRAMMER
K792590 · IOL
Burdick Corp.
Physical Medicine · 18d
Cleared Jan 04, 1980
STRESS TABLE/ERGOMETER SYSTEM
K792591 · ISD
Victoreen, Inc.
Radiology · 18d
Cleared Jan 04, 1980
DISPOSABLE INCENTIVE SPIROMETER
K792598 · BWF
Hospitak, Inc.
Anesthesiology · 17d
Cleared Jan 04, 1980
TEGTMEIER MAMMOMETER
K792608
Aztec Medical Products, Inc.
General & Plastic Surgery · 17d
Cleared Jan 04, 1980
SENTRY
K792653 · DXN
Automated Screening Devices
Cardiovascular · 9d
Cleared Jan 04, 1980
DATABASE MANAGEMENT & REPORTING SYSTEM
K792677 · DQK
Honeywell, Inc.
Cardiovascular · 8d
Cleared Dec 31, 1979
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K791455 · KTN
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-THYROGLOBULIN
K791458 · JZO
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-C-REACTIVE PROTEIN
K791461 · DCK
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-RHEUMATOID ARTHRITIS
K791507 · DHR
Volu Sol Medical Industries
Immunology · 152d
Cleared Dec 31, 1979
AVL MODEL 940 AUTOMATIC PH/BLOOD GAS
K792230 · CHL
Gauntlet Technology Corp.
Chemistry · 56d
Cleared Dec 31, 1979
SANDARE CYANMETHEMOGLOBIN STANDARD
K792358 · KRZ
Sandare Chemical Co., Inc.
Hematology · 40d
Cleared Dec 31, 1979
HANSAPOR STERILE
K792360 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 40d
Cleared Dec 31, 1979
SIM MEDIUM
K792420 · JSE
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Dec 31, 1979
DECARBOXYLASE BROTH BASE WITH OR WITH-
K792421 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Dec 31, 1979
TETRATHIONATE BROTH BASE
K792422 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Dec 31, 1979
CENTRIA FERRITIN RIA
K792449 · DBF
Union Carbide Corp.
Immunology · 31d
Cleared Dec 31, 1979
PLATELET-CHEX FOR BLOOD CENTERS
K792467 · JPK
Streck Laboratories, Inc.
Hematology · 28d