FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165577–165600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 26, 1980
DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM
K801948 · JAA
Technicare Corp.
Radiology · 42d
Cleared Sep 26, 1980
API-CTS STREPTOCOCCUS
K801951 · JTO
Analytical Products, Inc.
Microbiology · 39d
Cleared Sep 26, 1980
MICRO-FLOW SPECTROPHOTOMETER CL-720
K801957 · JJQ
Shimadzu Precision Instruments, Inc.
Chemistry · 39d
Cleared Sep 26, 1980
HEMO-CATH II KIDNEY DIALYSIS CATHETER
K801966 · FIE
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 26, 1980
MEDCOMP FEMORAL VEIN CATHETER
K801967 · FIF
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 26, 1980
HEMOCATH I KIDNEY DIALYSIS CATHETER
K801968 · LBW
Medical Components, Inc.
Gastroenterology & Urology · 38d