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
158665–158688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1982
TOXOPLASMA GONDII ANTIBODY IGG
K822605 · LJK
Immulok, Inc.
Microbiology · 61d
Cleared Oct 27, 1982
MICROFLUOR READER
K822772 · KHO
Dynatech Corp.
Chemistry · 43d
Cleared Oct 27, 1982
PICOLITE
K822800 · JJQ
United Technologies Packard
Chemistry · 40d
Cleared Oct 27, 1982
CONTAINERS OF STERILE WATER OS SALINE
K822811 · BTO
American Pharmaseal Div. Ahsc
Anesthesiology · 37d
Cleared Oct 27, 1982
HISH EIA DIAGNOSTIC KIT
K822827 · JLW
Abbott Laboratories
Chemistry · 36d
Cleared Oct 27, 1982
RADIOIMMUNOASSAY, HUMAN CHORRIONIC
K822840 · JHI
Bioclinical Group
Chemistry · 34d
Cleared Oct 27, 1982
SOPHEIA CORTISOL EIA KIT
K822845 · CGR
Diagnostic Products Corp.
Chemistry · 34d
Cleared Oct 27, 1982
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850 · JJY
American Dade
Chemistry · 34d
Cleared Oct 27, 1982
TRIGLYCERIDE CALIBRATOR
K822852 · JIT
Harleco Diagnostics
Chemistry · 33d
Cleared Oct 27, 1982
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS
K822860 · JQP
Ventrex Laboratories, Inc.
Chemistry · 30d
Cleared Oct 27, 1982
URIC ACID 75CDO
K822884 · CDO
Technicon Instruments Corp.
Chemistry · 29d
Cleared Oct 27, 1982
GONORRHEA TRANSETTE 3
K822886 · JSM
Spectrum Diagnostic, Inc.
Microbiology · 29d
Cleared Oct 27, 1982
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA
K822933 · LEG
Syva Co.
Chemistry · 23d
Cleared Oct 27, 1982
SYVA ADVANCE EMIT AED VALPROIC ACID CONT
K822934 · LAS
Syva Co.
Toxicology · 23d
Cleared Oct 27, 1982
ELLISON VITALLIUM FIXATION STAPLE SYS
K822943 · JDR
Howmedica Corp.
Orthopedic · 23d
Cleared Oct 27, 1982
MIDAS 1000 WRIGHT STAIN #66010
K822980 · IAF
Emd Chemicals, Inc.
Hematology · 19d
Cleared Oct 27, 1982
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
K822981 · IAF
Emd Chemicals, Inc.
Hematology · 19d
Cleared Oct 27, 1982
MIDAS 100 HEMACOLOR STAIN #66030
K822982 · HYB
Emd Chemicals, Inc.
Hematology · 19d
Cleared Oct 27, 1982
PEOPLE MOVER
K822992 · INM
Convaid Products, Inc.
Physical Medicine · 15d
Cleared Oct 27, 1982
Q65 MEDICAL TREADMILL
K823003 · IOL
Quinton, Inc.
Physical Medicine · 15d
Cleared Oct 26, 1982
SERA FOR ANTINUCLEAR ANTIBODIES
K820945 · DHN
Centers For Disease Control and...
Microbiology · 203d
Cleared Oct 26, 1982
FOLATE/B12 DUO-BEAD RADIOASSAY
K822241 · CEN
Abbott Laboratories
Chemistry · 91d
Cleared Oct 26, 1982
VARIOUS TYPES OF LIGHT SOURCE HANDLES
K822257 · EOQ
Kelleher Corp.
Ear, Nose, Throat · 89d
Cleared Oct 26, 1982
MICROMEDIC ESTRIOL RIA KIT
K822578 · CGI
Micromedic Systems
Chemistry · 62d