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
159073–159096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1982
YERSINIA SELECTIVE SUPPLEMENT
K822511 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 25d
Cleared Sep 14, 1982
B-HCG RADIOIMMUNOASSAY KIT
K822515 · JHI
Bioclinical Group
Chemistry · 25d
Cleared Sep 14, 1982
SINGLE CHANNEL NONFADE OSCILLOSCOPE
K822517 · DXJ
Quinton, Inc.
Cardiovascular · 25d
Cleared Sep 14, 1982
MULTIPLE, ENT CHAIR #418
K822530 · ETF
Midmark Corp.
Ear, Nose, Throat · 22d
Cleared Sep 14, 1982
NY FERMENTATION MEDIA
K822552 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Sep 14, 1982
CEMENT EXTRACTION INSTRUMENTATION
K822554
Surgi-Quip Inc.U
General & Plastic Surgery · 21d
Cleared Sep 14, 1982
LSM AGAR
K822558 · JWX
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Sep 14, 1982
SXT BLOOD AGAR
K822559 · JSJ
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Sep 14, 1982
MICROSCOPE
K822561 · EPT
Treace Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 14, 1982
OPHTHALMIC MICROSCOPE
K822563 · HRM
Treace Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 14, 1982
WATER BATH
K822564 · JTQ
Boekel Industries, Inc.
Microbiology · 21d
Cleared Sep 14, 1982
AURAL REFLEX INDICATOR
K822566 · ETY
Kelleher Corp.
Ear, Nose, Throat · 21d
Cleared Sep 14, 1982
EAR PROBES
K822568 · EKL
Kelleher Corp.
Dental · 21d
Cleared Sep 14, 1982
PERMA-SET INFUSION SET
K822603 · LDR
Cosmetic Sciences, Inc.
General Hospital · 18d
Cleared Sep 14, 1982
PRECAPSULED DENTAL AMALGAM
K822610 · DZS
Syntex Dental Products, Inc.
Dental · 15d
Cleared Sep 14, 1982
BEHIND-THE-EAR MODEL 115PPPCW
K822619 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 14, 1982
ELBOW PROSTHESIS
K822632 · IRE
Hosmer Dorrance Corp.
Physical Medicine · 14d
Cleared Sep 14, 1982
CLASS II DEVICE FOR I.C.P. MONITORING
K822636 · GWM
Philadelphia Medical Specialties
Neurology · 14d
Cleared Sep 14, 1982
OPTILUX & VISILUX DENTAL PHOTO LAMP
K822642 · EBZ
Demetron Research Corp.
Dental · 13d
Cleared Sep 14, 1982
BEHIND-THE-EAR MODEL 115 V AGC O W
K822655 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 13, 1982
STIMPEN
K822139 · BXN
Neuro Technology
Anesthesiology · 56d
Cleared Sep 13, 1982
LH (125I) RADIOIMMUNOASSAY
K822288 · CEP
Corning Medical & Scientific
Chemistry · 45d
Cleared Sep 13, 1982
ARMSTRONG V TUBE SUCTION INSERTER
K822349 · JYM
Treace Medical, Inc.
Ear, Nose, Throat · 38d
Cleared Sep 13, 1982
LEECO T4 QUANT DIAGNOSTICS TEST KIT
K822399 · CDX
Leeco Diagnostics, Inc.
Chemistry · 34d