FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75121–75144 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2002
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
K021959 · DQA
Dolphin Medical, Inc.
Anesthesiology · 27d
Cleared Jul 11, 2002
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K022087 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 14d
Cleared Jul 10, 2002
ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
K020668 · IYO
Aloka Co., Ltd.
Radiology · 131d
Cleared Jul 10, 2002
MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
K021601 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 56d
Cleared Jul 10, 2002
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
K021899 · DQY
Concentric Medical, Inc.
Cardiovascular · 30d
Cleared Jul 10, 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · IXA
Eastman Kodak Company
Radiology · 30d
Cleared Jul 09, 2002
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
K013418 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 267d
Cleared Jul 09, 2002
VP-2000/1000
K013434 · DXN
Colin Corp.
Cardiovascular · 266d
Cleared Jul 09, 2002
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
K013634 · FJK
Bioteque Corp.
Gastroenterology & Urology · 246d
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