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
63841–63864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2006
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
K052423 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 133d
Cleared Jan 13, 2006
TRACTION SYSTEM, DIGIT-TRAC 930
K052453 · ITH
Ever Prosperous Instrument, Inc.
Physical Medicine · 128d
Cleared Jan 13, 2006
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX
K052710 · EIH
Vident
Dental · 106d
Cleared Jan 13, 2006
SEVEN STAR NEEDLE
K052723 · MQX
Helio Medical Supplies, Inc.
General Hospital · 106d
Cleared Jan 13, 2006
IMPLANTMED SI-915 (115V VERSION)
K052741 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 105d
Cleared Jan 13, 2006
MICROSULIS TISSUE ABLATION SYSTEM
K052919 · NEY
Microsulis Americas, Inc.
General & Plastic Surgery · 88d
Cleared Jan 13, 2006
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
K052935 · MXK
Heidelberg Engineering
Ophthalmic · 86d
Cleared Jan 13, 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
K052976 · DQK
Ge Healthcare
Cardiovascular · 81d
Cleared Jan 13, 2006
MSAS-VANTAGE
K053004 · GZO
Biomeridian, Int.
Neurology · 79d
Cleared Jan 13, 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+...
K053110 · JGS
I-Stat Corporation
Chemistry · 70d
Cleared Jan 13, 2006
RANDOX CALIBRATION SERUM
K053153 · JIX
Randox Laboratories, Ltd.
Chemistry · 64d
Cleared Jan 13, 2006
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS,...
K053227 · FST
Medical Illumination International, Inc.
General & Plastic Surgery · 57d
Cleared Jan 13, 2006
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
K053247 · JJY
Maine Standards Co.
Chemistry · 53d
Cleared Jan 13, 2006
ENDIUS ATAVI SYSTEM
K053267 · HRX
Endius, Inc.
Orthopedic · 51d
Cleared Jan 13, 2006
CELL-CHEX AUTO
K053362 · JPK
Streck
Hematology · 42d
Cleared Jan 13, 2006
FRESH, DENTAL IMPRESSION MATERIAL
K053427 · ELW
Exacta Dental Products, Inc.
Dental · 36d
Cleared Jan 13, 2006
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND...
K053436 · OCL
Cryocath Technologies, Inc.
Cardiovascular · 35d
Cleared Jan 13, 2006
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,...
K053460 · MCW
Fox Hollow Technologies
Cardiovascular · 31d
Cleared Jan 13, 2006
HEMOSIL PROS
K053499 · GGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Jan 13, 2006
POWERPICC
K053501 · LJS
Bard Access Systems, Inc.
General Hospital · 28d
Cleared Jan 13, 2006
T-PIN
K053513 · JDW
Union Surgical, LLC
Orthopedic · 28d
Cleared Jan 13, 2006
SHORT CITATION FEMORAL STEM
K053528 · MEH
Stryker Orthopaedics
Orthopedic · 25d
Cleared Jan 13, 2006
PROFEMUR LX HIP STEM
K053588 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Jan 13, 2006
ALOKA SD-3500 ULTRASOUND SYSTEM
K060059 · IYN
Aloka Co., Ltd.
Radiology · 4d