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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
44017–44040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2012
OLEA SPHERE
K120196 · LLZ
Olea Medical
Radiology · 87d
Cleared Apr 19, 2012
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K120201 · IYO
Ge Vingmed Ultrasound AS
Radiology · 87d
Cleared Apr 19, 2012
EZONO 3000
K120234 · IYN
Life-Tech, Inc.
Radiology · 85d
Cleared Apr 19, 2012
PHILIPS MICRODOSE
K120255 · MUE
Philips Digital Mammography Sweden AB
Radiology · 83d
Cleared Apr 19, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K120316 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Apr 19, 2012
2MP MONOCHROME LCD MONITOR, RADIFORCE GX240
K120407 · LLZ
Eizo Nanao Corporation
Radiology · 70d
Cleared Apr 19, 2012
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
K120699 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 43d
Cleared Apr 19, 2012
INSTAPACS/INSTARISPACS
K120718 · LLZ
Meddiff Technologies Pvt. , Ltd.
Radiology · 42d
Cleared Apr 19, 2012
RIVAL PTA DILATATION CATHETER
K120722 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Apr 19, 2012
OTIS-C PLUS
K120818 · HRS
Science For Biomaterials
Orthopedic · 31d
Cleared Apr 19, 2012
PRE-LOADED GOLD VISICOIL CK MARKER
K120859 · KXK
Radiomed Corporation
Radiology · 28d
Cleared Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · DQX
Covidien, LLC
Cardiovascular · 28d
Cleared Apr 19, 2012
ORBIT
K120880 · BZG
National Biomedical, LLC Dba Qrs...
Anesthesiology · 27d
Cleared Apr 19, 2012
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 17d
Cleared Apr 19, 2012
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K121010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Apr 19, 2012
OPTIMA NM/CT 640
K121019 · KPS
Ge Healthcare
Radiology · 15d
Cleared Apr 18, 2012
WUNDER TEST
K102428 · LDJ
Hien Helen Nguyen
Toxicology · 601d
Cleared Apr 18, 2012
AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
K112440 · DZE
A.B. Dental Devices , Ltd.
Dental · 238d
Cleared Apr 18, 2012
TWIN PEAKS LUMBAR CAGE
K112696 · MAX
Qualgenix, LLC
Orthopedic · 216d
Cleared Apr 18, 2012
ZHENJIANG ASURE MECHANICAL WHEELCHAIR
K112816 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 203d
Cleared Apr 18, 2012
ON CALL CHOSEN LANCING DEVICE
K113332 · FMK
ACON Laboratories, Inc.
General & Plastic Surgery · 156d
Cleared Apr 18, 2012
NEXUS TKO-6, LUER-ACTIVATED DEVICE
K113398 · FPA
Nexus Medical, LLC
General Hospital · 153d
Cleared Apr 18, 2012
JAZZY ELITE 6
K113488 · ITI
Pride Mobility Product Corporration
Physical Medicine · 147d
Cleared Apr 18, 2012
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
K113586 · HQD
Synergeyes, Inc.
Ophthalmic · 135d