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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101809–101832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1995
SURGICAL TECHNOLOGIES, INC. SYRINGE
K951918 · FMF
Surgical Technologies, Inc.
General Hospital · 87d
Cleared Jul 20, 1995
CORDIS STEERABLE GUIDEWIRE
K952067 · DQX
Cordis Corp.
Cardiovascular · 79d
Cleared Jul 20, 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · CHH
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Jul 20, 1995
SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE
K952404 · LYY
Aladan Corp.
General Hospital · 59d
Cleared Jul 20, 1995
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES,...
K952574 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 45d
Cleared Jul 20, 1995
IL TEST LIPASE
K952647 · CHI
Instrumentation Laboratory CO
Chemistry · 41d
Cleared Jul 20, 1995
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K952681 · ERL
Stryker Endoscopy
Ear, Nose, Throat · 38d
Cleared Jul 20, 1995
HUMID-VENT 1
K952750 · BYD
Gibeck, Inc.
Anesthesiology · 35d
Cleared Jul 20, 1995
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · LYZ
Baxter Healthcare Corp
General Hospital · 31d
Cleared Jul 20, 1995
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM
K952813 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 31d
Cleared Jul 20, 1995
LIPASE FLEX REAGENT CARTRIDGE
K952816 · CHI
Dupont Medical Products
Chemistry · 30d
Cleared Jul 20, 1995
NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
K952824 · BZA
Intertex Medical, Inc.
Anesthesiology · 30d
Cleared Jul 20, 1995
HUMID-VENT 2
K952844 · BYD
Gibeck, Inc.
Anesthesiology · 29d
Cleared Jul 20, 1995
RIDGES PLUS
K952871 · KPR
Octostop, Inc.
Radiology · 51d
Cleared Jul 20, 1995
CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)
K953037 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 31d
Cleared Jul 20, 1995
MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES
K953208 · BXK
Standard Welders Supply Co.
Anesthesiology · 31d
Cleared Jul 19, 1995
SELECTA 20/60 CHEMISTRY ANALYZER
K942922 · JJE
Select Medical Systems, Inc.
Chemistry · 393d
Cleared Jul 19, 1995
MAXILUBE
K943010 · KMJ
Mission Pharmacal Co.
General Hospital · 390d
Cleared Jul 19, 1995
BIOFLEX GARMENTS, ASSORTED MODELS
K944543 · GXY
Bioflex, Inc.
Neurology · 307d
Cleared Jul 19, 1995
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
K944788 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 294d
Cleared Jul 19, 1995
BOBES LENS SET
K945443 · HPC
Bobes S.A.
Ophthalmic · 254d
Cleared Jul 19, 1995
DENTAL KIT
K945815 · EKJ
Constancy Ent., Inc.
Dental · 233d
Cleared Jul 19, 1995
DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP
K946046 · FQZ
Deroyal Critical Care, Div. Deroyal...
General Hospital · 219d
Cleared Jul 19, 1995
HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF...
K950354 · LCX
Ml Strategies, Inc.
Chemistry · 170d