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
74593–74616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2002
EIZO, MODEL FC-2091
K022109 · LLZ
Eizo Nanao Corporation
Radiology · 14d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · GEI
Boston Scientific Corp
General & Plastic Surgery · 232d
Cleared Jul 11, 2002
LUTZ NEEDLE
K013892 · BSP
Ballard Medical Products
Anesthesiology · 230d
Cleared Jul 11, 2002
NEUROTECH MEDISTIM PLUS, TYPE 291
K014019 · IPF
Bio-Medical Research, Ltd.
Physical Medicine · 217d
Cleared Jul 11, 2002
NT MEDITENS PLUS, TYPE 290
K014020 · GZJ
Bio-Medical Research, Ltd.
Neurology · 217d
Cleared Jul 11, 2002
FT101 FOREHEAD THERMOMETER
K020433 · FLL
Idt Technology Limited
General Hospital · 153d
Cleared Jul 11, 2002
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020792 · LDP
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jul 11, 2002
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020794 · DKJ
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jul 11, 2002
NO-POKES NEEDLE SAFETY DEVICE
K020921 · FMI
Bemis Mfg. Co.
General Hospital · 112d
Cleared Jul 11, 2002
ILT TORQUER, MODEL 114TR1
K021243 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 83d
Cleared Jul 11, 2002
MONARCH SPINE SYSTEM
K021335 · MNH
Depuyacromed
Orthopedic · 76d
Cleared Jul 11, 2002
DELIGHT DENTAL ER: YAG LASER SYSTEM
K021616 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 56d
Cleared Jul 11, 2002
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950...
K021817 · GEI
Aaron Medical Industries
General & Plastic Surgery · 38d
Cleared Jul 11, 2002
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
K021882 · DCN
Good Biotech Corp.
Immunology · 34d
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