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
149137–149160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1985
TITERTEK TWINREADER 78-630-00
K844567 · JJQ
Flow Laboratories, Inc.
Chemistry · 118d
Cleared Mar 21, 1985
BIOSAMPLER
K844615 · CBT
Biotek-Caribbean
Anesthesiology · 114d
Cleared Mar 21, 1985
BASIS DIGITAL THERMOMETER MODEL BTM-1
K844624 · FLL
Terayco Intl., Ltd.
General Hospital · 114d
Cleared Mar 21, 1985
ISIS
K844736 · LDK
Oxford Medilog, Inc.
Physical Medicine · 106d
Cleared Mar 21, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032 · DHB
Pharmacia, Inc.
Chemistry · 84d
Cleared Mar 21, 1985
KM PRODUCTS ASPIRATING TUBING
K850105 · BSY
Km Products
Anesthesiology · 69d
Cleared Mar 21, 1985
IN-TH-EAR HEARING AID
K850123 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Mar 21, 1985
CHLAMYDIA FLUORO-KIT 1680
K850158 · LJP
Clinical Sciences, Inc.
Microbiology · 65d
Cleared Mar 21, 1985
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER
K850384 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 48d
Cleared Mar 21, 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
K850488 · FRN
Strato Medical Corp.
General Hospital · 42d
Cleared Mar 21, 1985
ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM
K850533 · FPA
Atlantic Optical Systems, Inc.
General Hospital · 38d
Cleared Mar 21, 1985
ARGYLE 15MM SWIVEL CONNECTOR
K850625 · BZA
Sherwood Medical Co.
Anesthesiology · 30d
Cleared Mar 21, 1985
NASOPHARYNGEAL AIRWAY-ROBERTAZZI
K850644 · BTQ
Dryden Corp.
Anesthesiology · 30d
Cleared Mar 21, 1985
ENCORE FERRITIN REAGENT
K850680 · JMB
Hybritech, Inc.
Chemistry · 28d
Cleared Mar 21, 1985
PAD, PRE-OPERATIVE PREPARATION
K850811 · KME
East Texas Lighthouse For the Blind
General Hospital · 21d
Cleared Mar 21, 1985
ACTH II BY RADIOIMMUNOASSAY
K850882 · CKG
Immuno Nuclear Corp.
Chemistry · 17d
Cleared Mar 21, 1985
OPHTHALMIC DROPPER BOTTLES
K850962
Acacia, Inc.
Ophthalmic · 13d
Cleared Mar 21, 1985
ELECTRIC LIFT TABLE-OPHTHALMIC
K851008
Turbine Support Systems, Inc.
Ophthalmic · 9d
Cleared Mar 20, 1985
VISOPROTECT OCCULAR SHIELD
K850005 · HMP
M.S.G. Health Systems, Inc.
General & Plastic Surgery · 77d
Cleared Mar 20, 1985
VISOPROTECT: OCCULAR SHIELD
K850099 · HMP
Rockway Enterprises, Inc.
General & Plastic Surgery · 68d
Cleared Mar 20, 1985
FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G
K850127 · LIF
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 20, 1985
C.N.V.T.
K850299 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
MUCOLYSE
K850300 · JSK
Pro-Lab, Inc.
Microbiology · 57d
Cleared Mar 20, 1985
YEAST DIALYSATE
K850301 · JSK
Pro-Lab, Inc.
Microbiology · 57d