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
165841–165864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1980
BURRON MICROCATH INTRA. CATH. PLACEMENTT
K801941 · FOZ
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Aug 27, 1980
ASNIS GUIDED SCREW SYSTEMS
K801969 · HNC
Howmedica Corp.
Ophthalmic · 8d
Cleared Aug 22, 1980
AMPCO DRESSING CHANGE TRAYS
K801333 · FRG
Associated Medical Products Co.
General Hospital · 80d
Cleared Aug 20, 1980
AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS
K801331 · FRG
Associated Medical Products Co.
General Hospital · 78d
Cleared Aug 20, 1980
LATEX FOLEY CATHETER (HYDROMER COATED)
K801415 · KOD
G.D. Searle and Co.
Gastroenterology & Urology · 65d
Cleared Aug 20, 1980
ELECTRO-ACUSCOPE-70
K801459 · GZJ
Nebrensky Corp.
Neurology · 57d
Cleared Aug 20, 1980
BMC RIAFLO SYSTEM
K801481 · JJC
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Aug 20, 1980
ULTRAFREE CALCIUM FILTER
K801500 · JRL
Millipore Corp.
Chemistry · 54d
Cleared Aug 20, 1980
ANTIGEN CONTROL CELLS
K801507 · GOL
Ortho Diagnostics, Inc.
Microbiology · 51d
Cleared Aug 20, 1980
DOPPLER ULTRASONIC STETHOSCOPE
K801512 · IYN
Mountain Medical Equipment, Inc.
Radiology · 51d
Cleared Aug 20, 1980
SOLAR PACIFIC UVA SUNLAMP DEVICE
K801520 · LEJ
Solar Pacific
Radiology · 50d
Cleared Aug 20, 1980
CLASSIC TAN TANNING BOOTH
K801521 · LEJ
Classic Tan, Inc.
Radiology · 50d
Cleared Aug 20, 1980
WALL MOUNTED LASER POSITIONING DEVICE
K801541 · IWE
Advantage Medical Systems, Inc.
Radiology · 48d
Cleared Aug 20, 1980
SUNBED/SUNROOF OR SUNCOUCH/SUNSKY
K801542 · LEJ
Sunfit, Inc.
Radiology · 44d
Cleared Aug 20, 1980
PHOTOMETER LP 6
K801562 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
PHOTOMETER LP 3
K801563 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
PHOTOMETER LP 1
K801564 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
L-CATH INTRAVENOUS PLACEMENT UNIT
K801575 · FOZ
Luther Medical Products, Inc.
General Hospital · 43d
Cleared Aug 20, 1980
LEBODY BY WATER PIK
K801593 · ISA
Teledyne, Inc.
Physical Medicine · 37d
Cleared Aug 20, 1980
MARK V DUPLEX ULTRASONIC SCANNING SYSTEM
K801598 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 37d
Cleared Aug 20, 1980
CORNING 184 BLOOD GAS TONOMETER
K801599 · LCH
Corning Medical & Scientific
Chemistry · 37d
Cleared Aug 20, 1980
SHARPLAN 723 CO2 LASER SURGICAL SYSTEM
K801624 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 36d
Cleared Aug 20, 1980
SONACOLOR 6100
K801647 · DXY
Carolina Medical Electronics
Cardiovascular · 33d
Cleared Aug 20, 1980
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K801649 · KNK
Eastman Kodak Company
Chemistry · 33d