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
74617–74640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 190d
Cleared Jul 09, 2002
EASI 12 LEAD ALGORITHM
K020456 · DRW
Philips Medical Systems
Cardiovascular · 148d
Cleared Jul 09, 2002
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
K020527 · HQC
American Optisurgical, Inc.
Ophthalmic · 140d
Cleared Jul 09, 2002
AURORA DS
K021149 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Jul 09, 2002
TSRH SPINAL SYSTEM
K021170 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jul 09, 2002
STARLIGHT
K021207 · OAN
Orthomerica Products, Inc.
Neurology · 84d
Cleared Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · DHR
Diamedix Corp.
Immunology · 68d
Cleared Jul 09, 2002
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K021473 · DWJ
Augustine Medical, Inc.
Cardiovascular · 62d
Cleared Jul 09, 2002
CYPRESS ULTRASOUND SYSTEM
K021497 · IYN
Acuson Corp.
Radiology · 61d
Cleared Jul 09, 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 29d
Cleared Jul 09, 2002
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
K021908 · JWH
Stelkast Company
Orthopedic · 29d
Cleared Jul 09, 2002
MICROPLEX COIL SYSTEMS (MCS)
K021914 · HCG
MicroVention, Inc.
Neurology · 28d
Cleared Jul 09, 2002
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION...
K022050 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jul 08, 2002
S7 ELITE CP AP SYSTEM
K013909 · BZD
ResMed Corp
Anesthesiology · 224d
Cleared Jul 08, 2002
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
K021488 · FPA
B.Braun Medical, Inc.
General Hospital · 61d
Cleared Jul 05, 2002
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 143d
Cleared Jul 05, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818 · LYY
Allegiance Healthcare Corp.
General Hospital · 114d
Cleared Jul 05, 2002
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE...
K021007 · LYY
Tillotson Healthcare Corp.
General Hospital · 99d
Cleared Jul 05, 2002
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING...
K021119 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 88d
Cleared Jul 05, 2002
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
K021179 · OCY
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 81d
Cleared Jul 05, 2002
ULTRASONIC TIPS WITH DIAMOND COATING
K021253 · ELC
Sybron Endo/Analytic
Dental · 77d
Cleared Jul 05, 2002
EMBRYO BIOPSY MEDIUM
K021358 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 67d
Cleared Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · JFY
Bayer Corp.
Chemistry · 63d
Cleared Jul 05, 2002
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
K021730 · LZA
Glovco (M) Sdn. Bhd.
General Hospital · 42d