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
81913–81936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2000
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
K001032 · CHH
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 116d
Cleared Jul 24, 2000
BONUS MECHANICAL WHEELCHAIR
K001391 · IOR
Bonus Ent. Corp.
Physical Medicine · 83d
Cleared Jul 24, 2000
SURGITRON IEC II
K001407 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 81d
Cleared Jul 24, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
K001558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Jul 24, 2000
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
K001777 · ITI
Invacare Corp.
Physical Medicine · 41d
Cleared Jul 24, 2000
SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)
K001890 · IOR
Otto Bock Orthopaedische Industrie, Kg.
Physical Medicine · 33d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
K001929 · DFC
Wako Chemicals USA, Inc.
Chemistry · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
K001931 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
K001933 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
K001934 · DFC
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR...
K002071 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 17d
Cleared Jul 24, 2000
ATRIUM LITE MESH
K002093 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 13d
Cleared Jul 24, 2000
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · JMM
Roche Diagnostics Corp.
Chemistry · 265d
Cleared Jul 24, 2000
MACROSORBOS PROTECTIVE SHEET
K994158 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 228d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/DADE DEMENSION
K001919 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/ RA,500/1000,
K001920 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/EXPRESS 550
K001921 · DFC
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 21, 2000
RESOLUTION CHOLESTEROL MONITOR
K000610 · CHH
Lifestream Technologies, Inc.
Chemistry · 149d
Cleared Jul 21, 2000
CALCIJECT
K001050 · EJK
Centrix, Inc.
Dental · 112d
Cleared Jul 21, 2000
ARIA
K001317 · MWJ
Del Mar Medical Systems, LLC
Cardiovascular · 86d
Cleared Jul 21, 2000
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
K001390 · DSA
Biosense Webster, Inc.
Cardiovascular · 80d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
K001423 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
K001424 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
K001426 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d