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
42073–42096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2013
PHONAK TINNITUS BALANCE
K123450 · KLW
Phonak, LLC
Ear, Nose, Throat · 94d
Cleared Feb 11, 2013
SOLEA
K123494 · GEX
Convergent Dental, Inc.
General & Plastic Surgery · 90d
Cleared Feb 11, 2013
FILMARRAY RESPIRATORY PANEL (RP)
K123620 · OCC
Biofire Diagnostics, Inc.
Microbiology · 80d
Cleared Feb 11, 2013
BABYLANCE HEEL INCISION DEVICE
K130132 · FMK
Medipurpose Pte. , Ltd.
General & Plastic Surgery · 24d
Cleared Feb 08, 2013
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
K112616 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 519d
Cleared Feb 08, 2013
ALEXIS O WOUND PROTECTOR/RETRACTOR
K113268 · KGW
Applied Medical Resources Corp.
General & Plastic Surgery · 462d
Cleared Feb 08, 2013
MYOSURE INTRUMENT TRAY
K121280 · KCT
Hologic, Inc.
General Hospital · 284d
Cleared Feb 08, 2013
UNI-GOLD CRYPTOSPORIDIUM
K121565 · MHJ
Trinity Biotech
Microbiology · 255d
Cleared Feb 08, 2013
ADENOVIRUS R-GENE US
K121942 · OCC
Argene SA
Microbiology · 221d
Cleared Feb 08, 2013
DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
K122065 · NOF
Ormco Corp.
Dental · 210d
Cleared Feb 08, 2013
VICTUS FEMTOSECOND LASER PLATFORM
K122386 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 186d
Cleared Feb 08, 2013
COMPACT DIGITAL BLOOD PRESSURE MONITOR
K122810 · DXN
Thermor , Ltd.
Cardiovascular · 148d
Cleared Feb 08, 2013
SURGERY REHEARSAL PLATFORM
K123023 · LLZ
Surgical Theater, LLC
Radiology · 133d
Cleared Feb 08, 2013
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET,...
K123131 · MRG
Tosoh Bioscience, Inc.
Chemistry · 127d
Cleared Feb 08, 2013
DIAGNOSTIC ULTRASOUND SYSTEM
K123249 · IYN
Edan Instruments, Inc.
Radiology · 114d
Cleared Feb 08, 2013
PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
K123308 · JOW
Albahealth, LLC
Cardiovascular · 107d
Cleared Feb 08, 2013
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
K123488 · LZA
Puyang Linshi Health Co., Ltd.
General Hospital · 87d
Cleared Feb 08, 2013
OPTIMA CT520
K123596 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 79d
Cleared Feb 08, 2013
PROFEMUR TL CLASSIC HIP STEM
K123688 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Feb 08, 2013
PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
K123799 · DJG
Psychemedics Corp.
Toxicology · 60d
Cleared Feb 08, 2013
4MP COLOR LCD MONITOR, RADIFORCE RX440
K130070 · LLZ
Eizo Nanao Corporation
Radiology · 28d
Cleared Feb 08, 2013
CORONIS FUSION 6MP
K130103 · LLZ
Barco N.V.
Radiology · 24d
Cleared Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558 · NBW
Lifescan, Inc.
Chemistry · 349d
Cleared Feb 07, 2013
M2 WRIST MRI SYSTEM
K120701 · LNH
Aspect Imaging, Ltd.
Radiology · 337d