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
137809–137832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1987
POROUS COATED ACETABULAR CUP
K873585 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 54d
Cleared Oct 28, 1987
BONE PIN CUTTER 18
K873715 · HXZ
Military Engineering, Inc.
Orthopedic · 43d
Cleared Oct 28, 1987
IOI BIPOLAR PROSTHESIS
K873815 · KWY
Intermedics Orthopedics
Orthopedic · 37d
Cleared Oct 28, 1987
ALTAIREX BUCKY/CASSETTE TRAY COMBINATION
K873849 · IXQ
Altairex Manufacturing, Inc.
Radiology · 36d
Cleared Oct 28, 1987
EMIT GENTAMICIN ASSAY
K873854 · LCD
Syva Co.
Toxicology · 36d
Cleared Oct 28, 1987
HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013
K873872 · DHA
Medix Biotech, Inc.
Chemistry · 36d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHADONE ASSAYS
K873899 · DJR
Syva Co.
Toxicology · 34d
Cleared Oct 28, 1987
READING CHARTS-CARDS (DISTANCE AND NEARPOINT)
K873909 · HOX
Richmond Products, Inc.
Ophthalmic · 33d
Cleared Oct 28, 1987
JACKSON CROSS CYLINDER TEST
K873915 · HOR
Richmond Products, Inc.
Ophthalmic · 33d
Cleared Oct 28, 1987
HEAD & CHIN RESTS
K873918 · HRH
Richmond Products, Inc.
Ophthalmic · 34d
Cleared Oct 28, 1987
TANGENT SCREEN
K873919 · HOJ
Richmond Products, Inc.
Ophthalmic · 33d
Cleared Oct 28, 1987
PREMIER-TOTAL (TM) HIP
K873999 · JDI
Intermedics Orthopedics
Orthopedic · 27d
Cleared Oct 28, 1987
STAPHSLIDE
K874019 · JWX
Ncs Diagnostics, Inc.
Microbiology · 26d
Cleared Oct 28, 1987
MULTICHEM INORGANIC PHOSPHOROUS S0923
K874038 · CEO
Simmler, Inc.
Chemistry · 23d
Cleared Oct 28, 1987
IRON REAGENT
K874055 · JMO
Trace Scientific , Ltd.
Chemistry · 23d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
K874079 · LDJ
Syva Co.
Toxicology · 22d
Cleared Oct 28, 1987
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
K874156 · LDJ
Syva Co.
Toxicology · 15d
Cleared Oct 28, 1987
BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)
K874172 · JSJ
Otisville Biopharm, Inc.
Microbiology · 15d
Cleared Oct 28, 1987
BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI
K874173 · JSJ
Otisville Biopharm, Inc.
Microbiology · 15d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199 · KXS
Syva Co.
Toxicology · 14d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS
K874200 · JXN
Syva Co.
Toxicology · 14d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY
K874201 · DIO
Syva Co.
Toxicology · 14d
Cleared Oct 27, 1987
TELSTAR PREWIRE SERIES
K871731 · LRS
Telstar Electronics, Inc.
General & Plastic Surgery · 175d
Cleared Oct 27, 1987
IN THE EAR & IN THE CANAL HEARING AID FACE PLATE
K871884 · LRB
Hearing Services, Inc.
Ear, Nose, Throat · 167d