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

Filters: Cleared only ×
176,076 results
166417–166440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1980
URINE COLLECTION CONTAINERS, #3600 &3610
K801786 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 30, 1980
NU-VISION DISP. OPHTHALMIC DRESSING TRAY
K801822 · KYG
Summit Optics, Inc.
Ophthalmic · 61d
Cleared Sep 26, 1980
CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL
K792377 · DHX
Environmental Chemical Specialties
Immunology · 305d
Cleared Sep 26, 1980
BIFOCAL 2 8200 SERIES (A,B C,D)
K800379 · DXY
American Pacemaker Corp.
Cardiovascular · 217d
Cleared Sep 26, 1980
HEARTWATCH
K800519 · DRT
D. Jenkins
Cardiovascular · 204d
Cleared Sep 26, 1980
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
K800857 · LCP
Helena Laboratories
Hematology · 164d
Cleared Sep 26, 1980
MEDTRONIC MODEL 69575
K800944 · DTB
Medtronic Vascular
Cardiovascular · 157d
Cleared Sep 26, 1980
HALL ARTERIAL OSCILLATOR
K801063 · DWX
American Sterilizer Co.
Cardiovascular · 143d
Cleared Sep 26, 1980
CLINETICS PCA COLUMN
K801306 · DHX
Clinetics Corp.
Immunology · 115d
Cleared Sep 26, 1980
ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM
K801451 · FJG
Medical, Inc.
Gastroenterology & Urology · 95d
Cleared Sep 26, 1980
UV URIC ACID STANDARDS
K801501 · JIS
The Dow Chemical Co.
Chemistry · 91d
Cleared Sep 26, 1980
AUTO SECTOR SCANNER
K801655 · IYN
Unirad Corp.
Radiology · 67d
Cleared Sep 26, 1980
EDP 1200 SECTOR SCANNER OPTION
K801656 · IYN
Unirad Corp.
Radiology · 67d
Cleared Sep 26, 1980
ETHICON RETRACTION TAPE
K801699 · GAD
Ethicon, Inc.
General & Plastic Surgery · 65d
Cleared Sep 26, 1980
EMBRIA-CK
K801728 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 64d
Cleared Sep 26, 1980
BR 2002 X-RAY GENERATOR SYSTEM
K801808 · IZO
Valmet Indus. Mach. & Prod., Inc.
Radiology · 58d
Cleared Sep 26, 1980
RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.
K801825 · FJI
Renal Systems, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 26, 1980
RENAFLO HOLLOW FIBER DIALYZERS #MP 140
K801826 · FJI
Renal Systems, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 26, 1980
RENAFLO HOLLOW FIBER DIALYZER #100.1
K801827 · FJI
Renal Systems, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 26, 1980
MODEL 203S CLINICAL CHEMISTRY ANALYZER
K801889 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 49d
Cleared Sep 26, 1980
KEITHLEY LYMPHOCYTE DEPLETION CART
K801899 · KDK
Keithley Development Co.
Gastroenterology & Urology · 49d
Cleared Sep 26, 1980
LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
K801909 · DEX
J.T. Baker Chemical Co.
Immunology · 46d
Cleared Sep 26, 1980
MICROLAB M-MICROPROCESSOR DILUTER/DISP
K801913 · JQW
Hamilton Co.
Chemistry · 46d
Cleared Sep 26, 1980
RHYTIDOMETER
K801939 · FTY
Aztec Medical Products, Inc.
General & Plastic Surgery · 45d