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
154273–154296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1984
NEUROTRON 100
K833086 · GZJ
Neutro-Tronics
Neurology · 113d
Cleared Jan 24, 1984
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN
K833402 · DEW
Technicon Instruments Corp.
Chemistry · 116d
Cleared Jan 24, 1984
IMMOPHASE D-TE 3 RADIOIMMUNOASSAY
K833406 · CGF
Corning Medical & Scientific
Chemistry · 116d
Cleared Jan 24, 1984
NATURELLE II & LITE II-N72-N74-L
K833774 · EJS
Jeneric Ind.
Dental · 89d
Cleared Jan 24, 1984
FILAFEX ESTHETIC ORTHODINIC WIRE
K833788 · DZC
Berkley and Co.
Dental · 85d
Cleared Jan 24, 1984
PHASE II THEOPHYLLINE RADIOIMMUNOASSAY
K833789 · LCA
Medical & Scientific Designs, Inc.
Chemistry · 85d
Cleared Jan 24, 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794 · DIF
Bio-Rad
Chemistry · 84d
Cleared Jan 24, 1984
URINE THC CANNABINOIDS DIRECT RIA KIT
K833911 · LAT
Immunalysis Corporation
Toxicology · 71d
Cleared Jan 24, 1984
COAT-A-COUNT NHS-PROLACTIN KIT AND
K833925 · CFT
Diagnostic Products Corp.
Chemistry · 71d
Cleared Jan 24, 1984
MICROLAB M DILUTER/DISPENSER
K833959 · JQW
Syva Co.
Toxicology · 69d
Cleared Jan 24, 1984
TECHNICON RA-1000 SYSTEM
K833992 · JGS
Technicon Instruments Corp.
Chemistry · 64d
Cleared Jan 24, 1984
BIO-SCIENCE LABORATORIES T4 REAGENT
K834023 · CDX
Biosan Laboratories, Inc.
Chemistry · 63d
Cleared Jan 24, 1984
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
K834052 · KLT
Abbott Laboratories
Toxicology · 62d
Cleared Jan 24, 1984
EMIT QST PHENOBARBITAL ASSAY
K834216 · DLZ
Syva Co.
Toxicology · 50d
Cleared Jan 24, 1984
THEOFAST TEST KIT FOR QUANTITATIVE THEO
K834244 · KLS
Allergenetics
Toxicology · 48d
Cleared Jan 24, 1984
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294 · LCP
Emd Chemicals, Inc.
Hematology · 47d
Cleared Jan 24, 1984
BEAR VENTI--VOICE
K834555 · ESE
Bear Medical Systems, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 24, 1984
C3 ANTISERUM CONTROL
K834604 · CZW
Technicon Instruments Corp.
Immunology · 116d
Cleared Jan 24, 1984
C4 ANTIGEN ANTIBODY CONTROL
K834605 · DBI
Technicon Instruments Corp.
Immunology · 116d
Cleared Jan 23, 1984
K-FLEX OSTOMY POUCH
K840266
Coloplast A/S
Gastroenterology & Urology
Cleared Jan 20, 1984
RESPITRACE 300SC
K823780 · BZK
Respitrace Corp.
Anesthesiology · 401d
Cleared Jan 20, 1984
CHLORIDE REAGENT SET
K832438 · CHJ
Amresco, Inc.
Chemistry · 179d
Cleared Jan 20, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
K834140 · KTL
Intl. Diagnostic Technology
Immunology · 51d
Cleared Jan 19, 1984
DECUBITUS CARE ABSORBENT DRESSING
K832407 · FRO
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 182d