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
37849–37872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2014
Q-STATION
K140808 · LLZ
Philips Ultrasound, Inc.
Radiology · 16d
Cleared Apr 16, 2014
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY...
K132620 · NDN
Pan Medical , Ltd.
Orthopedic · 238d
Cleared Apr 16, 2014
PVMED DDR 2430T
K133524 · MQB
Portavision Medical, LLC
Radiology · 152d
Cleared Apr 16, 2014
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
K133707 · MQL
Origio A/S
Obstetrics & Gynecology · 133d
Cleared Apr 16, 2014
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
K133783 · FIP
Ameriwater
Gastroenterology & Urology · 125d
Cleared Apr 16, 2014
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
K133791 · NHA
Sterngold Dental, LLC
Dental · 124d
Cleared Apr 16, 2014
INTESS CERVICAL CAGE SYSTEM
K133815 · ODP
Kalitec Direct, LLC
Orthopedic · 121d
Cleared Apr 16, 2014
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
K140092 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 92d
Cleared Apr 16, 2014
TRUEPATH CTO DEVICE
K140288 · PDU
Boston Scientific Corp
Cardiovascular · 70d
Cleared Apr 16, 2014
FREELITE HUMAN LAMBDA FREE KIT
K140396 · DEH
The Binding Site Group , Ltd.
Immunology · 57d
Cleared Apr 16, 2014
ROTATING ADAPTERS
K140475 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 49d
Cleared Apr 16, 2014
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K140639 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 35d
Cleared Apr 16, 2014
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
K140664 · DEB
The Binding Site Group , Ltd.
Immunology · 29d
Cleared Apr 16, 2014
INSERTION TOOL
K140673 · DQX
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 15, 2014
COGENT MED-LIF
K132738 · MAX
Cogent Spine, LLC
Orthopedic · 224d
Cleared Apr 15, 2014
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
K133389 · NBW
Eps Bio Technology Corp.
Chemistry · 161d
Cleared Apr 15, 2014
6200 / 6250 ULTRASOUND SYSTEM
K133905 · IYN
Esaote, S.P.A.
Radiology · 113d
Cleared Apr 15, 2014
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
K140503 · GEX
Boston Scientific
General & Plastic Surgery · 47d
Cleared Apr 15, 2014
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
K140831 · FPA
Care Fusion
General Hospital · 13d
Cleared Apr 14, 2014
DISCOSCOPES, CERVICAL ENDOSCOPES
K130778 · HRX
Rz Medizintechnik GmbH
Orthopedic · 389d
Cleared Apr 14, 2014
AVANCE® FOAM ABDOMINAL DRESSING KIT
K130852 · OXJ
Molnlycke Health Care
General & Plastic Surgery · 382d
Cleared Apr 14, 2014
MYHEALTHPOINT TELEHEALTH MANAGER
K132930 · DRG
Entra Health Systems
Cardiovascular · 208d
Cleared Apr 14, 2014
ERCHONIA ALLAY
K132940 · NHN
Erchonia Medical, Inc.
Physical Medicine · 207d
Cleared Apr 14, 2014
CERVICAL STAND ALONE SYSTEM
K132999 · OVE
Orthofix, Inc.
Orthopedic · 202d