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
47497–47520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2011
ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
K111227 · IYN
Aloka Co., Ltd.
Radiology · 11d
Cleared May 13, 2011
CLICK-IT
K111234 · NJM
Tp Orthodontics, Inc.
Dental · 11d
Cleared May 13, 2011
HEISENBERG DYEING LIQUIDS
K111257 · EIH
3M Espe AG
Dental · 9d
Cleared May 12, 2011
AURADORM (NEUROMUSCULAR SLEEP)
K101155 · LRK
Sleepwright
Dental · 381d
Cleared May 12, 2011
SEASPINE SPACER SYSTEM
K102026 · MAX
Seaspine, Inc.
Orthopedic · 297d
Cleared May 12, 2011
AVEA VENTILATOR
K103211 · CBK
Care Fusion
Anesthesiology · 192d
Cleared May 12, 2011
UPD-Y0003
K103312 · FDF
Olympus Medical Systems Corporation
Gastroenterology & Urology · 183d
Cleared May 12, 2011
ROCHE ELECSYS FOLATE RBC
K103716 · CGN
Roche Diagnostics
Chemistry · 142d
Cleared May 12, 2011
DROPPER A1C DIABETES CONTROL
K103744 · JJX
Quantimetrix Corp.
Chemistry · 140d
Cleared May 12, 2011
MUSTANG BALLOON DILATAION CATHETERS
K110122 · FGE
Boston Scientific
Gastroenterology & Urology · 114d
Cleared May 12, 2011
ACTIVECARE SFT
K110159 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 113d
Cleared May 12, 2011
CLEARBLUE EASY PREGNANCY TEST
K110433 · LCX
SPD Development Company Limited
Chemistry · 86d
Cleared May 12, 2011
ELECSYS PROLACTIN II CALCHECK 5
K110613 · JJX
Roche Diagnostics
Chemistry · 70d
Cleared May 12, 2011
SIMPLEABI
K110628 · JAF
Newman Medical
Radiology · 70d
Cleared May 12, 2011
STREAMLINE TL SPINAL SYSTEM
K110692 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 62d
Cleared May 11, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
K100910 · DHB
Siemens Medical Solutions Diagnostics
Immunology · 405d
Cleared May 11, 2011
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH...
K103523 · FPL
International Biomedical, Ltd.
General Hospital · 161d
Cleared May 11, 2011
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH...
K103525 · FPL
International Biomedical, Ltd.
General Hospital · 161d
Cleared May 11, 2011
ACHILLES
K103633 · MUA
Ge Medical Systems China Co., Ltd.
Radiology · 149d
Cleared May 11, 2011
ASPIRA PLEURAL DRAINAGE SYSTEM
K110409 · DWM
C.R. Bard, Inc.
Anesthesiology · 86d
Cleared May 11, 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
K110413 · CDD
Beckman Coulter, Inc.
Chemistry · 86d
Cleared May 11, 2011
DOLPHIN IMAGING
K110430 · LLZ
Patterson Dental Supply, Inc.
Radiology · 86d
Cleared May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
K110528 · FSR
Integra LifeSciences Corporation
Ophthalmic · 76d
Cleared May 11, 2011
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
K110965 · KTT
Renovis Surgical Technologies, LLC
Orthopedic · 35d