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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118009–118032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1992
ABBOTT SMART CAP
K915304 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 90d
Cleared Feb 19, 1992
KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915309 · LZO
Kinamed, Inc.
Orthopedic · 89d
Cleared Feb 19, 1992
KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915310 · LZO
Kinamed, Inc.
Orthopedic · 89d
Cleared Feb 19, 1992
URODYNAMIC CATHETER
K915443 · FAP
Cook Urological, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 19, 1992
WATERS 717 AUTOSAMPLER
K920136 · LDM
Millipore Corp.
Toxicology · 37d
Cleared Feb 19, 1992
RIONET HEARING AID HB-23T
K920521 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 15d
Cleared Feb 19, 1992
RIONET HEARING AID HB-23M
K920522 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 15d
Cleared Feb 18, 1992
SCANLAN/TAHERI VALVULOTOME
K911184 · MGZ
Scanlan Intl., Inc.
Cardiovascular · 337d
Cleared Feb 18, 1992
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
K912444 · LGM
Radiometer America, Inc.
General Hospital · 260d
Cleared Feb 18, 1992
HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K912778 · JWY
Sensititre Microbiology A Div. of...
Microbiology · 239d
Cleared Feb 18, 1992
GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE
K913696 · LDQ
Vertex Technical Group, Inc.
General & Plastic Surgery · 183d
Cleared Feb 18, 1992
IL TEST(TM) AMLYLASE
K913744 · JFJ
Instrumentation Laboratory CO
Chemistry · 182d
Cleared Feb 18, 1992
CONTINUUM KNEE SYSTEM (CKS)
K914072 · JWH
Techmedica, Inc.
Orthopedic · 160d
Cleared Feb 18, 1992
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135 · CFT
Amersham Corp.
Chemistry · 155d
Cleared Feb 18, 1992
XLP NETWORK PRINTING
K914191 · LMD
Vortech Data, Inc.
Radiology · 153d
Cleared Feb 18, 1992
UNIVERSAL FEMORAL NAIL
K914371 · JDS
Synthes (Usa)
Orthopedic · 140d
Cleared Feb 18, 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · JDS
Synthes (Usa)
Orthopedic · 137d
Cleared Feb 18, 1992
CYTOLOGY BRUSH
K914504 · FDX
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 132d
Cleared Feb 18, 1992
SMALL JOINT SYSTEM
K914559 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 126d
Cleared Feb 18, 1992
ELECTONE/PA RECHARGEABLE
K914795 · ESD
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
PREMIER ASP/CD RECHARGEABLE
K914796 · ESD
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
PREMIER CD RECHARGEABLE
K914797 · ESD
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
PREMIER CLASS D-ASP
K914798 · ESD
Electone, Inc.
Ear, Nose, Throat · 118d
Cleared Feb 18, 1992
PREMIER K-AMP
K914799 · ESD
Electone, Inc.
Ear, Nose, Throat · 118d