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
174025–174048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1977
ENIT ABA THYROXINE ASSAY
K770070 · KLI
Syva Co.
Chemistry · 8d
Cleared Jan 21, 1977
ROBBETT MICROSURGICAL LARYNGOSCOPE
K770085 · EQN
Edward Weck, Inc.
Ear, Nose, Throat · 7d
Cleared Jan 21, 1977
FLUORICON 500 IMAGE INTENSIFIERS
K770094 · EAM
General Electric Co.
Radiology · 4d
Cleared Jan 18, 1977
COLPOSCOPICALLY DIRECTED OB/GYN LASER
K761347 · HHR
Photon Sources
Obstetrics & Gynecology · 21d
Cleared Jan 18, 1977
CERVICAL-VAGINAL SPATULA
K761348 · HHT
Law Offices of Natter & Natter
Obstetrics & Gynecology · 21d
Cleared Jan 18, 1977
MPX 80
K770006 · IZO
General Electric Co.
Radiology · 15d
Cleared Jan 18, 1977
MPX 100
K770007 · IZO
General Electric Co.
Radiology · 15d
Cleared Jan 18, 1977
MPX 125
K770008 · IZO
General Electric Co.
Radiology · 15d
Cleared Jan 18, 1977
MIRROR, LARYNGEAL
K770053 · KAI
Welch Allyn, Inc.
Ear, Nose, Throat · 8d
Cleared Jan 18, 1977
MIRROR, NASO-PHARYNX
K770054 · KAI
Welch Allyn, Inc.
Ear, Nose, Throat · 8d
Cleared Jan 18, 1977
DIGOXIN CLASP TM RIA KIT
K770069 · DPO
E. R. Squibb & Sons, Inc.
Toxicology · 5d
Cleared Jan 17, 1977
TERASAKI LYMPHOCYTE TRANSPORT KIT
K760952 · KSR
Dravon Medical, Inc.
Hematology · 76d
Cleared Jan 17, 1977
LYSING AGENT AF
K761183 · JCE
Central Labs. Assoc. MD Pathologists
Pathology · 46d
Cleared Jan 17, 1977
MASK, FACE, SURGICAL
K770021 · CAD
Precept, Inc.
Anesthesiology · 11d
Cleared Jan 14, 1977
GP3%SP-2100DOHON100/120 MESH SUPELCOPORT
K761226 · JSQ
Supelco, Inc.
Microbiology · 36d
Cleared Jan 14, 1977
MODEL 738 BIRT-A-PAD
K761231 · GEI
Birtcher Corp.
General & Plastic Surgery · 35d
Cleared Jan 14, 1977
NEOMYCIN AGAR WITH 5% SHEEP BLOOD
K761359 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 16d
Cleared Jan 14, 1977
P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM
K770004 · JSJ
Scott Laboratories, Inc.
Microbiology · 11d
Cleared Jan 14, 1977
PACING KIT, ELECATH TRANSTHORACIC
K770016 · DTR
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
PACING KIT, TRANSMYOCARDIAL
K770017 · DTR
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
PACING KIT, SEMI-FLOATING
K770018 · DTR
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
SCREW, WADSWORTH OLECRANON
K770035 · HWC
Orthopedic Equipment Co., Inc.
Orthopedic · 4d
Cleared Jan 14, 1977
CARDIOTOMY RESERVOIR
K770036 · DTN
Shiley, Inc.
Cardiovascular · 4d
Cleared Jan 14, 1977
ELECTROCARDIOGRAPH MODEL 344
K770037 · DPS
Birtcher Corp.
Cardiovascular · 4d