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
157753–157776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1983
SPIROTECH 300
K823771 · BTY
Spirotech, Inc.
Anesthesiology · 45d
Cleared Jan 28, 1983
ULTRAZYME PLUS GAMMA-GT, #64959/65032
K823883 · JQB
Emd Chemicals, Inc.
Chemistry · 32d
Cleared Jan 28, 1983
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY
K823887 · KLR
Syva Co.
Toxicology · 32d
Cleared Jan 28, 1983
COLLAR BUTTON VENT TUBE
K823907 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 28, 1983
GROMMET VENT TUBE
K823908 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 31d
Cleared Jan 28, 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929 · JJY
Fisher Scientific Co., LLC
Chemistry · 30d
Cleared Jan 28, 1983
CPAP INFANT NASAL CANNULAE SET
K823936 · BZD
Ackrad Laboratories
Anesthesiology · 30d
Cleared Jan 28, 1983
WAKO INSULIN TEST
K823939 · CFP
Wako Chemicals USA, Inc.
Chemistry · 30d
Cleared Jan 28, 1983
ACRYLIC SHEET, PLEXIGLASS MC
K830031
Summit Orthodontic Services, Inc.
Dental · 21d
Cleared Jan 28, 1983
TOTAL IRON BINDING CAPACITY TEST
K830032 · JQF
Sclavo, Inc.
Chemistry · 21d
Cleared Jan 28, 1983
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
K830035 · LFM
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jan 28, 1983
NEONATAL NTSH RADIOIMMUNOASSAY SYS
K830036 · JLW
Corning Medical & Scientific
Chemistry · 21d
Cleared Jan 28, 1983
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL
K830049 · LAS
Syva Co.
Chemistry · 18d
Cleared Jan 28, 1983
COLLAR BUTTON VENT TUBE
K830085 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Jan 28, 1983
USCI ELECTRONIC MANOMETER
K830093 · DRS
C.R. Bard, Inc.
Cardiovascular · 17d
Cleared Jan 28, 1983
RAPID CHEM ANALYZER II
K830095 · JJF
Macomb Chemical Co.
Toxicology · 17d
Cleared Jan 28, 1983
PHADEBAS & PHADEZYME RAST ALLERGEN DISC
K830096 · DHB
Pharmacia, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
AUFRANC-TURNER ATS METAL BACKED ACETABU
K830097 · DXQ
Howmedica Corp.
Cardiovascular · 17d
Cleared Jan 28, 1983
COLORIMETERS SERIES ONE 12
K830101 · JJQ
Innotron of Oregon, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
SERUM IRON DIAGNOSTIC TEST KITS
K830104 · CEM
Sclavo, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
NEEDLE CATHETER JEJUNOSTOMY KIT
K830119 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 28, 1983
ARTERIAL BLOOD FILTER AF-1025-AF-1025BL
K830131 · DTM
American Bentley
Cardiovascular · 16d
Cleared Jan 28, 1983
ARTERIAL BLOOD FILTER AF-1040-AF-1040BL
K830132 · DTM
American Bentley
Cardiovascular · 16d
Cleared Jan 27, 1983
INTRACATH-DA INTRAVENOUS CATH. PLACEMENT
K823064 · DQO
Parke-Davis Co.
Cardiovascular · 101d