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
73609–73632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2002
OPTICAL INTEGRITY GENERAL SHAPED FIBER
K022338 · GEX
Optical Integrity, Inc.
General & Plastic Surgery · 90d
Cleared Oct 16, 2002
DIODENT DENTAL LASER SYSTEM
K022351 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 89d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE,...
K022357 · DQX
Boston Scientific, Target
Cardiovascular · 89d
Cleared Oct 16, 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
K022637 · HMY
Becton, Dickinson & CO
Ophthalmic · 69d
Cleared Oct 16, 2002
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K022754 · DXC
S & T AG
Cardiovascular · 58d
Cleared Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · MKW
Dade Behring, Inc.
Chemistry · 30d
Cleared Oct 16, 2002
OLEEVA FABRIC
K023136 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 26d
Cleared Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 8d
Cleared Oct 15, 2002
POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE
K022016 · LYY
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 117d
Cleared Oct 15, 2002
SANARUS VISICA TREATMENT SYSTEM
K022314 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Oct 15, 2002
POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE...
K022566 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 74d
Cleared Oct 15, 2002
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
K022668 · GKZ
Bayer Diagnostics Corp.
Hematology · 64d
Cleared Oct 11, 2002
REPROCESSED IMAGING CATHETERS
K012537 · OWQ
Sterilmed, Inc.
Cardiovascular · 430d
Cleared Oct 11, 2002
KOWA AUTOMATED TONOMETER KT-500
K013805 · HKX
Kowa Optimed, Inc.
Ophthalmic · 330d
Cleared Oct 11, 2002
QUANTUM, MODELS SR, HR, DL
K020839 · GEX
Lumenis, Inc.
General & Plastic Surgery · 210d
Cleared Oct 11, 2002
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL
K020936 · MSD
Medcomp
Gastroenterology & Urology · 203d
Cleared Oct 11, 2002
NEICH NM ADVANCE CATHETER SHEATH INTRODUCER
K020964 · DYB
Neich Medical(Shenzhen)Company, Ltd.
Cardiovascular · 200d
Cleared Oct 11, 2002
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300
K021087 · DQD
Erecords Limited
Cardiovascular · 191d
Cleared Oct 11, 2002
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL...
K021446 · BTM
Oemedic International, Inc.
Anesthesiology · 158d
Cleared Oct 11, 2002
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS...
K021752 · HQD
Lucid Korea Co., Ltd.
Ophthalmic · 136d
Cleared Oct 11, 2002
COMFORT DREAMRIDER SCOOTER, LY-EW402
K021910 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 123d
Cleared Oct 11, 2002
TGDC-01 PRA
K021937 · HKX
Truevision Instruments
Ophthalmic · 121d
Cleared Oct 11, 2002
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM)...
K022117 · DRC
Merit Medical Systems, Inc.
Cardiovascular · 102d
Cleared Oct 11, 2002
STOCKERT CORONARY PERFUSION CANNULAE
K022280 · DWF
Stockert Instrumente GmbH
Cardiovascular · 88d