FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83737–83760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2000
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · KXS
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · KLT
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988 · DIO
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004 · LSR
Inova Diagnostics, Inc.
Microbiology · 64d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
K994017 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
K994020 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
K994030 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · ELW
GC America, Inc.
Dental · 56d
Cleared Jan 27, 2000
IMPREGUM GARANT L DUOSOFT
K994190 · ELW
Espe Dental AG
Dental · 45d
Cleared Jan 27, 2000
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · LJT
Sims Deltec, Inc.
General Hospital · 43d
Cleared Jan 24, 2000
BABY DOPPLEX 4000, MODEL BD 4000
K990569 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 335d
Cleared Jan 24, 2000
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
K992786 · FIP
Pure Water, Inc.
Gastroenterology & Urology · 158d
Cleared Jan 24, 2000
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL...
K993058 · FIN
Pure Water, Inc.
Gastroenterology & Urology · 133d
Cleared Jan 24, 2000
MD 420/440/460/470/480/490
K993200 · FIP
Isopure, Corp.
Gastroenterology & Urology · 122d
Cleared Jan 24, 2000
POWERHEART AECD
K993533 · MKJ
Cardiac Science, Inc.
Cardiovascular · 97d
Cleared Jan 24, 2000
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K993622 · GZL
Alpha Omega , Ltd.
Neurology · 90d
Cleared Jan 24, 2000
CANDELA SCLERO LONG PULSE DYE LASER
K993671 · GEX
Candela Corp.
General & Plastic Surgery · 84d
Cleared Jan 24, 2000
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS)...
K993961 · LDJ
American Bio Medica Corp.
Toxicology · 63d
Cleared Jan 24, 2000
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
K994263 · HFW
Precision Dynamics Corp.
Obstetrics & Gynecology · 38d
Cleared Jan 24, 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K994418 · HIH
Ethicon, Inc.
Obstetrics & Gynecology · 26d
Cleared Jan 21, 2000
DERMAFREEZE
K992286 · MLY
Rhealm Pharmaceuticals, Inc.
Physical Medicine · 198d
Cleared Jan 21, 2000
MRP-TITAN
K992403 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 186d
Cleared Jan 21, 2000
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
K992855 · QPB
Xomed, Inc.
General & Plastic Surgery · 150d
Cleared Jan 21, 2000
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH...
K993415 · HCG
Boston Scientific, Target
Neurology · 112d