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
78361–78384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130 · JJX
Dade Behring, Inc.
Chemistry · 29d
Cleared Oct 18, 2001
MR-GUIDE 2000
K013150 · LNH
Ultraguide , Ltd.
Radiology · 28d
Cleared Oct 18, 2001
MOSFET AUTOSENSE, MODEL TN-RD-60
K013279 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 16d
Cleared Oct 17, 2001
SEED SELECTRON MODEL V. 1.0
K010032 · JAQ
Nucletron Corp.
Radiology · 287d
Cleared Oct 17, 2001
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011247 · MQX
Acusupply, Inc.
General Hospital · 177d
Cleared Oct 17, 2001
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
K012265 · FCW
Circon Video
Gastroenterology & Urology · 90d
Cleared Oct 17, 2001
THEKEN SMALL CEMENT RESTRICTOR
K012278 · JDK
Theken Surgical,Llc
Orthopedic · 90d
Cleared Oct 17, 2001
FLEXI-SITE SP02 EAR SENSOR
K012333 · DPZ
Epic Medical Equipment Services, Inc.
Anesthesiology · 85d
Cleared Oct 17, 2001
VANGUARD REPROCESSED COMPRESSION GARMENT
K012403 · JOW
Vanguard Medical Concepts, Inc.
Cardiovascular · 79d
Cleared Oct 17, 2001
SONICATOR PLUS 930, MODEL ME 930
K013192 · IMI
Mettler Electronics Corp.
Physical Medicine · 22d
Cleared Oct 17, 2001
LUXABITE
K013236 · ELW
Dmg USA, Inc.
Dental · 19d
Cleared Oct 16, 2001
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
K011337 · JOZ
Accumetrics, Inc.
Hematology · 167d
Cleared Oct 16, 2001
VERTRAN STANDING WHEELCHAIR
K011530 · IPL
Fena Design, Inc.
Physical Medicine · 152d
Cleared Oct 16, 2001
VBR
K012254 · MQP
Osteotech, Inc.
Orthopedic · 90d
Cleared Oct 16, 2001
ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K012339 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 84d
Cleared Oct 16, 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · HRX
Vanguard Medical Concepts, Inc.
Orthopedic · 84d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Oct 16, 2001
ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K012499 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 74d
Cleared Oct 16, 2001
REVOTEK LC
K012542 · EBC
GC America, Inc.
Dental · 70d
Cleared Oct 16, 2001
POLY STAT HCG TEST
K012559 · JHI
Bion Diagnostic Sciences
Chemistry · 69d
Cleared Oct 16, 2001
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
K012878 · JIS
Thermo Dma, Inc.
Chemistry · 49d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900 · JIT
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Oct 16, 2001
ALGO 3 NEWBORN HEARING SCREENER
K013137 · GWJ
Natus Medical, Inc.
Neurology · 27d
Cleared Oct 16, 2001
HRH-63-8 HEAD ARRAY COIL
K013159 · MOS
Mri Devices Corp.
Radiology · 25d