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
79057–79080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2001
SIGMA DELTA
K002343 · CAD
Penlon , Ltd.
Anesthesiology · 311d
Cleared Jun 08, 2001
ORIGEN DUAL LUMEN CATHETER
K003288 · DQO
Origen Biomedical, Inc.
Cardiovascular · 231d
Cleared Jun 08, 2001
MAR COR SERVICES BICARB SYSTEM
K003560 · FIN
Mar Cor Services, Inc.
Gastroenterology & Urology · 203d
Cleared Jun 08, 2001
BREAST-BOARD (MULTIPLE)
K003778 · IYE
Arplay Medical S.A.
Radiology · 183d
Cleared Jun 08, 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · DXN
Welch Allyn, Inc.
Cardiovascular · 137d
Cleared Jun 08, 2001
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
K010791 · DXH
Adsis , Ltd.
Cardiovascular · 85d
Cleared Jun 08, 2001
CARDIAC VIEW, MODEL 2001
K010802 · MOS
Magna-Lab, Inc.
Radiology · 84d
Cleared Jun 08, 2001
INSULIN PEN NEEDLE ADAPTER
K010887 · FMI
Ohana Needle Co.
General Hospital · 74d
Cleared Jun 08, 2001
MEDLEY SP02 MODULE, MODEL 8220
K010966 · DQA
Alaris Medical Systems, Inc.
Anesthesiology · 67d
Cleared Jun 08, 2001
AIRLIFE HEPA FILTER
K011132 · CAH
Allegiance Healthcare Corp.
General Hospital · 56d
Cleared Jun 08, 2001
ONE-STEP PLUS
K011159 · EMA
Bisco, Inc.
Dental · 58d
Cleared Jun 08, 2001
ULTRASOUND SCANNER, TYPE 2102
K011417 · IYO
B & K Medical A/S
Radiology · 30d
Cleared Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · LDP
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 08, 2001
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL...
K011494 · JJY
Bio-Rad
Immunology · 24d
Cleared Jun 08, 2001
INFANT FLOW SYSTEM, MODEL M672P
K011516 · BZD
Eme (Electro Medical Equipment) , Ltd.
Anesthesiology · 22d
Cleared Jun 08, 2001
VERDICT -II TCA, VERDICT-II MTD
K011545 · LFG
Medtox Diagnostics, Inc.
Toxicology · 21d
Cleared Jun 08, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K011578 · MWI
Agilent Technologies, Inc.
Cardiovascular · 17d
Cleared Jun 08, 2001
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX
K011601 · BTA
Ardo Medical AG
General & Plastic Surgery · 15d
Cleared Jun 08, 2001
LIVESURE AMPHETAMINE SCREEN TEST
K011609 · DKZ
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
LIVESURE METHAMPHETAMINE SCREEN TESTS
K011610 · LAF
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
CARDIOCAM MODEL 9CSY0799
K011611 · KPS
Danish Diagnostic Development A/S
Radiology · 14d
Cleared Jun 08, 2001
LIFEJET PRINTER 400
K011617 · LMC
Ferrania S.P.A. Stabilimento DI Ferrania
Radiology · 14d
Cleared Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · JAA
GE Medical Systems
Radiology · 14d
Cleared Jun 07, 2001
XSCAN32 TELERADIOLOGY SOFTWARE
K002911 · LLZ
Radiographic Digital Imaging, Inc.
Radiology · 262d