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
82993–83016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154 · LPH
Plus Orthopedics
Orthopedic · 286d
Cleared Apr 06, 2000
ESKA MODULAR HIP SYSTEM
K993027 · LPH
Specs USA, Inc.
Orthopedic · 210d
Cleared Apr 05, 2000
ACTICOAT FOAM DRESSING
K000051 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 89d
Cleared Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
K000235 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 69d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
RANDOX CALCIUM
K000375 · CIC
Randox Laboratories, Ltd.
Chemistry · 58d
Cleared Apr 05, 2000
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
K000466 · DJR
Dade Behring, Inc.
Toxicology · 54d
Cleared Apr 05, 2000
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
K000489 · LLL
Helix Diagnostics, Inc.
Immunology · 51d
Cleared Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · DHR
Roche Diagnostics Corp.
Immunology · 48d
Cleared Apr 05, 2000
DIMENSION PENTA L
K000595 · ELW
Espe Dental AG
Dental · 43d
Cleared Apr 05, 2000
FLEXTIME
K000629 · ELW
Heraeus Kulzer, Inc.
Dental · 41d
Cleared Apr 05, 2000
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING...
K000725 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 30d
Cleared Apr 05, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000872 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 16d
Cleared Apr 05, 2000
SKYLIGHT IMAGING SYSTEM
K000908 · KPS
Adac Laboratories
Radiology · 15d
Cleared Apr 05, 2000
LUXAFORM
K000951 · EBG
Dmg USA, Inc.
Dental · 13d
Cleared Apr 05, 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K992781 · JJX
Bio-Rad
Immunology · 230d
Cleared Apr 04, 2000
RENAFLO II HF 2000 HEMOFILTER
K000028 · KDI
Minntech Corp.
Gastroenterology & Urology · 90d
Cleared Apr 04, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
K000029 · DTB
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Apr 04, 2000
SUNI MAX
K000049 · EFB
Satelec
Dental · 88d
Cleared Apr 04, 2000
PROVEN KNEE SYSTEM
K000113 · JWH
Stelkast Company
Orthopedic · 81d
Cleared Apr 04, 2000
MEDISUL DISPOSABLE VAGINAL SPECULUM
K000414 · HIB
Marketing Perspectives
Obstetrics & Gynecology · 56d
Cleared Apr 04, 2000
MS-ONE, MODEL MS-1
K994065 · IPF
Home Wellness West
Physical Medicine · 125d