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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49009–49032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2010
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND...
K101368 · FPA
Dragon Heart Medical, Inc.
General Hospital · 185d
Cleared Nov 18, 2010
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
K102043 · MSD
Rex Medical
Gastroenterology & Urology · 121d
Cleared Nov 18, 2010
VELSCOPE VX
K102083 · NXV
Led Dental, Inc.
Dental · 115d
Cleared Nov 18, 2010
CRITICOOL PRO
K102112 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 113d
Cleared Nov 18, 2010
BAHADIR STERILIZATION TRAYS
K102146 · KCT
Bahadir USA Corp.
General Hospital · 111d
Cleared Nov 18, 2010
HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
K102236 · INK
D.T. Davis Enterprises Ltd. T/A...
Physical Medicine · 101d
Cleared Nov 18, 2010
MICROPLEX COIL SYSTEM- COSMOS
K102365 · KRD
MicroVention, Inc.
Neurology · 90d
Cleared Nov 18, 2010
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O
K102377 · CAP
A Plus Medical
Anesthesiology · 90d
Cleared Nov 18, 2010
MOORVMS-PRES PRESSURE CUFF CONTROLLER
K102433 · DPW
Moor Instruments, Ltd.
Cardiovascular · 84d
Cleared Nov 18, 2010
WIRELESS DR IMAGING OPTION-WDR1
K102615 · MQB
Ge Medical Systems, LLC
Radiology · 70d
Cleared Nov 18, 2010
ELECSYS PTH CALCHECK 5
K103162 · JJX
Roche Diagnostics
Chemistry · 22d
Cleared Nov 17, 2010
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
K093071 · HKI
Fundus Photo, LLC
Ophthalmic · 413d
Cleared Nov 17, 2010
BGM GALECTIN -3
K093758 · OSX
Bg Medicine, Inc.
Chemistry · 345d
Cleared Nov 17, 2010
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW,...
K101436 · LZC
Shen Wei (Usa), Inc.
General Hospital · 177d
Cleared Nov 17, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102097 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 113d
Cleared Nov 17, 2010
POWERPICC SV CATHETERS
K102159 · LJS
C.R. Bard, Inc.
General Hospital · 107d
Cleared Nov 17, 2010
MUCOGRAFT
K102531 · NPL
Ed. Geistlich Soehne AG Fur Chemische...
Dental · 75d
Cleared Nov 17, 2010
CHITOGAUZE
K102546 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 75d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Nov 17, 2010
SA FLOWABLE ADHESIVE
K102603 · EBF
Dmg USA, Inc.
Dental · 68d
Cleared Nov 17, 2010
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K102650 · IYE
Accuray Incorporated
Radiology · 64d
Cleared Nov 17, 2010
CONCENTRIC BALLOON GUIDE CATHETER
K102657 · DQY
Concentric Medical, Inc.
Cardiovascular · 63d
Cleared Nov 17, 2010
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
K102668 · JWY
BIOMERIEUX
Microbiology · 62d
Cleared Nov 17, 2010
DIODE LASER THERAPY SYSTEM
K102669 · GEX
China Daheng Group, Inc.
General & Plastic Surgery · 62d