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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138985–139008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1987
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
K870176 · LKT
Genetic Systems Corp.
Microbiology · 182d
Cleared Jul 16, 1987
NITROGLYCERINE PUMP SET
K871084 · FRN
Churchill Corp.
General Hospital · 120d
Cleared Jul 16, 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
K871137 · DQX
Dlp, Inc.
Cardiovascular · 118d
Cleared Jul 16, 1987
DELFLEX RIGID DRAIN CONTAINER
K871155 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 16, 1987
KUMAR CERVICAL APPLICATOR
K871213 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 112d
Cleared Jul 16, 1987
HENSCHKE AFTERLOADING APPLICATOR
K871217 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 112d
Cleared Jul 16, 1987
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
K871220 · HHR
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 118d
Cleared Jul 16, 1987
MURRAY/WELCH TOTAL HIP SYSTEM
K871402 · JDI
Kirschner Medical Corp.
Orthopedic · 99d
Cleared Jul 16, 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · BYE
Respironics, Inc.
Anesthesiology · 87d
Cleared Jul 16, 1987
ROKONICS 8500
K871576 · BZQ
Rokonics, Inc.
Anesthesiology · 85d
Cleared Jul 16, 1987
CLEARFIL POSTERIOR 3
K871635 · EBF
Kuraray Co.
Dental · 80d
Cleared Jul 16, 1987
NEUROCOM PRESSURE TEST SYSTEM
K871652 · ETY
Neurocom International, Inc.
Ear, Nose, Throat · 79d
Cleared Jul 16, 1987
NICOLET AMP 6R11 SYSTEM
K871678 · GWL
Nicolet Biomedical Instruments
Neurology · 79d
Cleared Jul 16, 1987
ALTERNARIA TENUIS ALLERGEN DISC
K871684 · DHB
Incstar Corp.
Immunology · 78d
Cleared Jul 16, 1987
VAS-CATH PERITONEAL DIALYSIS CATHETER
K871817 · FJS
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 66d
Cleared Jul 16, 1987
V-MARC 88A COMPUTER
K871853 · JQP
V.Marc, A Div. of Pictorial, Inc.
Chemistry · 65d
Cleared Jul 16, 1987
UROVIEW
K872022 · KQS
Oec-Diasonics, Inc.
Gastroenterology & Urology · 51d
Cleared Jul 16, 1987
CARBON ELECTRODE
K872044 · GXY
Futuremed Div. of Future Impex Corp.
Neurology · 50d
Cleared Jul 16, 1987
SPERM WASHING MEDIUM #9932
K872102 · HDR
Irvine Scientific
Obstetrics & Gynecology · 45d
Cleared Jul 16, 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130 · JHI
Syva Co.
Chemistry · 44d
Cleared Jul 16, 1987
PORTABLE DENTAL X-RAY UNIT MODEL 4000
K872240 · EHD
Home/Office Dental, Inc.
Radiology · 35d
Cleared Jul 16, 1987
CHOLESTEROL REAGENT
K872295 · CHH
Sigma Diagnostics, Inc.
Chemistry · 30d
Cleared Jul 16, 1987
DYNATECH SPD 3000, #002-900-0000
K872363 · JQW
Dynatech Laboratories, Inc.
Chemistry · 28d
Cleared Jul 16, 1987
VICE OR BENCH VICE
K872385 · LSA
Med-Tool, Inc.
General & Plastic Surgery · 27d