Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79729–79752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · MNI
Interpore Cross Intl.
Orthopedic · 27d
Cleared Jun 06, 2001
QED DIODE DETECTORS, MODELS 1112-1116
K011466 · LNH
Sun Nuclear Corp.
Radiology · 23d
Cleared Jun 06, 2001
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
K011485 · LNH
Fonar Corp.
Radiology · 22d
Cleared Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · DLZ
Syva Co.
Chemistry · 20d
Cleared Jun 05, 2001
STRYKER PAINPUMP PCA
K003543 · FRN
Stryker Instruments
General Hospital · 200d
Cleared Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429 · MMI
Beckman Coulter, Inc.
Chemistry · 112d
Cleared Jun 05, 2001
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K010682 · MUJ
Mds Nordion
Radiology · 90d
Cleared Jun 05, 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 89d
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