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
85465–85488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1999
RADIFOCUS OPTITORQUE
K992051 · DQO
Terumo Medical Corp.
Cardiovascular · 53d
Cleared Aug 10, 1999
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
K992252 · LYF
Chemicon Intl., Inc.
Microbiology · 35d
Cleared Aug 10, 1999
AIA-PACK FOLATE ASSAY
K992365 · CGN
Tosoh Medics, Inc.
Chemistry · 26d
Cleared Aug 10, 1999
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · DJG
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Aug 10, 1999
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · BZR
Sechrist Industries, Inc.
Anesthesiology · 14d
Cleared Aug 09, 1999
CADPLAN HELIOS OPTION 6.0
K984532 · MUJ
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Aug 09, 1999
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · GMZ
Meridian Diagnostics, Inc.
Microbiology · 194d
Cleared Aug 09, 1999
SAS ROTA TEST
K990842 · LIQ
Sa Scientific, Inc.
Microbiology · 147d
Cleared Aug 09, 1999
TOUCH TEAR IGE MICROASSAY KIT
K991316 · DGC
Touch Scientific, Inc.
Immunology · 112d
Cleared Aug 09, 1999
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA,...
K991623 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 90d
Cleared Aug 09, 1999
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
K991628 · GEX
Esc Medical Systems, Inc.
General & Plastic Surgery · 90d
Cleared Aug 09, 1999
KRONUS OPTIQUANT THYROGLOBULIN KIT
K991720 · MSW
Unchanged
Immunology · 81d
Cleared Aug 09, 1999
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
K991890 · MVJ
Cogent Diagnotics , Ltd.
Immunology · 67d
Cleared Aug 09, 1999
3M LVR SYSTEM
K991961 · EBF
3M Company
Dental · 60d
Cleared Aug 09, 1999
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · ETA
Micromedics, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 09, 1999
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K992428 · LYY
Tillotson Healthcare Corp.
General Hospital · 19d
Cleared Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA)...
K990666 · MEH
Smith & Nephew, Inc.
Orthopedic · 157d
Cleared Aug 06, 1999
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · MXK
Nidek, Inc.
Ophthalmic · 113d
Cleared Aug 06, 1999
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
K991715 · MAI
Linvatec Corp.
Orthopedic · 78d
Cleared Aug 06, 1999
SALTER LABS PEP DEVICE
K991788 · CAF
Salter Labs
Anesthesiology · 73d
Cleared Aug 06, 1999
ULTIMAX ANKLE FUSION ROD SYSTEM
K991790 · HSB
Encore Orthopedics, Inc.
Orthopedic · 72d
Cleared Aug 06, 1999
VHS SUPRACONDYLAR PLATE SYSTEM
K991806 · KTT
Walter Abendschein, M.D.
Orthopedic · 72d
Cleared Aug 06, 1999
MACMED PAEDIATRIC INTRAMEDULLARY NAIL
K991877 · JDS
Innervision, Inc.
Orthopedic · 65d
Cleared Aug 06, 1999
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
K992040 · HRX
Fiber Imaging Technologies, Inc.
Orthopedic · 50d