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
155137–155160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1983
AUGROS HYSTEROMETER
K831224 · HHM
Axcan Scientific Corp.
Obstetrics & Gynecology · 196d
Cleared Oct 28, 1983
ELECTRONEURAL STIMULATOR 12
K831487 · GZJ
Meridia 12 Corp.
Neurology · 171d
Cleared Oct 28, 1983
CRITIKON CARDIAC OUTPUT COMPUTER
K831967 · DXG
Critikon Company, LLC
Cardiovascular · 130d
Cleared Oct 28, 1983
HEMOCUE PHOTOMETER TECHNICAL MANUAL
K832020 · GKR
Aktiebolaget Leo Diagnostics
Hematology · 135d
Cleared Oct 28, 1983
AMES TDA NETILMICIN TEST & SERUM
K832088 · LCE
Miles Laboratories, Inc.
Chemistry · 122d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
K832257 · CZN
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN IGM H CHAIN
K832259 · DFT
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN LAMBA AFFINITY
K832261 · DEH
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
FITC GOAT ANTI-HUMAN IGG Y CHAIN
K832264 · DEW
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Oct 28, 1983
CRASH CART
K832355 · BZN
Quinton, Inc.
Anesthesiology · 102d
Cleared Oct 28, 1983
PORTABLE OPERAT. RM. MONITORS HS30/40
K832356 · BZN
Medtel Pty. , Ltd.
Anesthesiology · 102d
Cleared Oct 28, 1983
VERIMED MYOEXORCISER
K832714 · HCC
Verimed Holdings, Inc.
Neurology · 77d
Cleared Oct 28, 1983
ERYTHROCYTE TEST
K832771 · LKZ
Bio-Analytics Laboratories, Inc.
Hematology · 73d
Cleared Oct 28, 1983
AGAR 8000 TENS
K832851 · GZJ
Kimed Industries, Inc.
Neurology · 67d
Cleared Oct 28, 1983
B-SLIDE PREGNATE PREGNANCY TEST KIT
K832879 · JHJ
Fisher Scientific Co., LLC
Chemistry · 63d
Cleared Oct 28, 1983
MODIFIED CHORIO-SHURE
K832892 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 63d
Cleared Oct 28, 1983
ENZYMATIC GLUCOSE DETERMINATION
K832926 · CGA
Seragen Diagnostics, Inc.
Chemistry · 70d
Cleared Oct 28, 1983
BUN LIQUID STABLE REAGENT SET
K832941 · CDQ
Medical Analysis Systems, Inc.
Chemistry · 59d
Cleared Oct 28, 1983
GAS CHROMATOGRAPH 5890A
K832962 · KZQ
Hewlett-Packard Co.
Chemistry · 59d
Cleared Oct 28, 1983
ELECTRODES FOR BLOOD GAS ANALYZERS
K832981 · CHL
Analytical Products, Inc.
Chemistry · 56d
Cleared Oct 28, 1983
DISPOSA-LITE LARYNGOSCOPE BLADE
K832984 · CCW
Michael S. Upsher
Anesthesiology · 56d
Cleared Oct 28, 1983
PARAMAX SALICYLATE REAGENT
K833003 · DKJ
American Dade
Chemistry · 77d
Cleared Oct 28, 1983
HAEMOPHILUS/NEISSERIA IDENTIF-PANEL
K833027
American Micro Scan
Microbiology · 51d
Cleared Oct 28, 1983
PALLADENT
K833049 · EJS
Jeneric Ind.
Dental · 51d