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
125017–125040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1990
TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
K901247 · DYG
Intec Medical, Inc.
Cardiovascular · 138d
Cleared Jul 31, 1990
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252 · DXQ
Hewlett-Packard Co.
Cardiovascular · 137d
Cleared Jul 31, 1990
ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
K901994 · EFW
Rosofsky & Ross, Inc.
Dental · 90d
Cleared Jul 31, 1990
FUJI LINING CEMENT LIGHT CURE
K901999 · EJK
G-C Intl. Corp.
Dental · 90d
Cleared Jul 31, 1990
MOVABLE CORE GUIDEWIRE
K902152 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 77d
Cleared Jul 31, 1990
TEFLON COATED GUIDEWIRE
K902153 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 76d
Cleared Jul 31, 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174 · LBR
Coulter Corp.
Chemistry · 78d
Cleared Jul 31, 1990
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · JGY
Data Medical Associates, Inc.
Chemistry · 76d
Cleared Jul 31, 1990
SUBCLAVIAN INTRODUCER SET
K902251 · DYB
Infusaid Corp.
Cardiovascular · 76d
Cleared Jul 31, 1990
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K902270 · LJC
Ciba Corning Diagnostics Corp.
Microbiology · 71d
Cleared Jul 31, 1990
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K902326 · JFJ
Catachem, Inc.
Chemistry · 68d
Cleared Jul 31, 1990
NF-50-E DISPOSABLE ECG ELECTRODE
K902407 · DRX
Medicotest, Inc.
Cardiovascular · 61d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
K902661 · GQL
Baxter Healthcare Corp
Microbiology · 43d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
K902662 · GQL
Baxter Healthcare Corp
Microbiology · 43d
Cleared Jul 31, 1990
MULTI ANALYTE MIXTURE, CALIBRATORS
K902675 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 31, 1990
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K902776 · JJQ
Slt Labinstruments, Inc.
Chemistry · 36d
Cleared Jul 31, 1990
RUBELLA IGG
K902793 · LFX
Pharmacia Diagnostics, Inc.
Microbiology · 35d
Cleared Jul 31, 1990
VISI-DRAPE OPHTHALMIC DRAPES
K902857 · HMY
Visitec Co.
Ophthalmic · 32d
Cleared Jul 31, 1990
SYNERMED SERUM IRON REAGENT KIT
K902918 · CFM
Synermed, Inc.
Chemistry · 28d
Cleared Jul 31, 1990
SYNERMED MAGNESIUM REAGENT KIT
K902919 · JGJ
Synermed, Inc.
Chemistry · 28d
Cleared Jul 31, 1990
TURBO-RAST SPECIFIC IGE ASSAY
K903000 · JHR
Ventrex Laboratories, Inc.
Immunology · 22d
Cleared Jul 30, 1990
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
K896787 · GZJ
Saratoga Intl., Inc.
Neurology · 238d
Cleared Jul 30, 1990
MUSTANG, C.A.T.
K901957 · EJF
Lancer Orthodontics, Inc.
Dental · 90d
Cleared Jul 30, 1990
GUARDIAN SAFE BOW
K901958 · DZB
Lancer Orthodontics, Inc.
Dental · 90d