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
79129–79152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2001
PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
K010824 · MEB
Science Incorporated
General Hospital · 78d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 61d
Cleared Jun 05, 2001
DELDENT ULTRASONIC INSERTS
K011179 · ELC
Deldent , Ltd.
Dental · 49d
Cleared Jun 05, 2001
POWDER-FREE VINYL EXAM GLOVE, YELLOW
K011413 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 28d
Cleared Jun 05, 2001
POWDERED VINAL EXAM GLOVES
K011414 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 28d
Cleared Jun 05, 2001
CARMEN
K011425 · EIH
Dentaurum, Inc.
Dental · 27d
Cleared Jun 05, 2001
TRICERAM
K011428 · EIH
Dentaurum, Inc.
Dental · 27d
Cleared Jun 05, 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · FRN
Abbott Laboratories
General Hospital · 26d
Cleared Jun 05, 2001
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING...
K011563 · LYY
U.O.P. Rubber Products Sdn Bhd
General Hospital · 15d
Cleared Jun 05, 2001
SIMPLICITY SOFT QD SILVER INFUSION SET
K011580 · FPA
Sterling Medivations, Inc.
General Hospital · 14d
Cleared Jun 04, 2001
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
K003472 · CAW
Sequal Technologies, Inc.
Anesthesiology · 208d
Cleared Jun 04, 2001
TDP CQ-27 HEAT LAMP
K003538 · ILY
Lhasa Medical, Inc.
Physical Medicine · 200d
Cleared Jun 04, 2001
CONTINUOUS FLOW Y-TUBING
K010122 · LJH
G.U.-Tek
Gastroenterology & Urology · 139d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · MNI
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 04, 2001
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
K010667 · KDI
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jun 04, 2001
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
K010669 · GWQ
Thuris Corp.
Neurology · 90d
Cleared Jun 01, 2001
SPINAL EPIDURAL NEEDLES
K002405 · BSP
Te ME NA S.A.R.L.
Anesthesiology · 298d
Cleared Jun 01, 2001
JET SYRINGE MODEL-100500
K003741 · KZE
Equidyne Systems, Inc.
General Hospital · 179d
Cleared Jun 01, 2001
RESPIRATORY HUMIDIFIER, MODEL HC150
K003973 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 161d
Cleared Jun 01, 2001
PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K003992 · NFA
Percu Surge, Inc.
Cardiovascular · 157d
Cleared Jun 01, 2001
KOKO PEAK KP
K010009 · BZH
Pds Healthcare Products, Inc.
Anesthesiology · 150d
Cleared Jun 01, 2001
VERDICT -II METHAMPHETAMINE
K010226 · DJC
Medtox Diagnostics, Inc.
Toxicology · 128d
Cleared Jun 01, 2001
ISCREEN VISION SCREENER
K010315 · HKI
Iscreen, LLC
Ophthalmic · 119d
Cleared Jun 01, 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K011020 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 58d