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
46081–46104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2011
EASYSCAN MODEL 1.2
K111988 · MYC
I-Optics BV
Ophthalmic · 107d
Cleared Oct 28, 2011
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS
K112107 · GWQ
Neurovirtual USA, Inc.
Neurology · 98d
Cleared Oct 28, 2011
CHX=CHX PLUS
K112250 · KJJ
Inter-Med, Inc.
Dental · 85d
Cleared Oct 28, 2011
NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS
K112259 · NHA
Nobel Biocare AB
Dental · 81d
Cleared Oct 28, 2011
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K112277 · PSZ
Becton, Dickinson and Company
Microbiology · 80d
Cleared Oct 28, 2011
SOFRELINER TOUGH S
K112445 · EBI
Tokuyama Dental Corporation
Dental · 65d
Cleared Oct 28, 2011
SYRINGES AND NEEDLES
K113091 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 9d
Cleared Oct 27, 2011
AESCULAP- MEITHKE SHUNT SYSTEM
K110206 · JXG
Aesculap, Inc.
Neurology · 275d
Cleared Oct 27, 2011
OSRAM ITOS
K110326 · ERA
Osram Sylvania, Inc.
Ear, Nose, Throat · 266d
Cleared Oct 27, 2011
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
K110655 · NKB
Mahe Medical GmbH
Orthopedic · 234d
Cleared CT Oct 27, 2011
SPIDERFX EMBOLIC PROTECTION DEVICE
K111010 · NTE
Ev3, Inc.
Cardiovascular · 199d
Cleared Oct 27, 2011
ZOLL RESCUENETLINK
K111296 · MSX
Zoll Medical Corporation, World Wide...
Cardiovascular · 171d
Cleared Oct 27, 2011
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
K111434 · MUE
Giotto USA, LLC
Radiology · 157d
Cleared CT Oct 27, 2011
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K111723 · MCW
Ev3, Inc.
Cardiovascular · 129d
Cleared Oct 27, 2011
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · KWQ
Zimmer Spine, Inc.
Orthopedic · 122d
Cleared Oct 27, 2011
JMS APHERESIS NEEDLE SET WINGEATER(R) V2
K112178 · FIE
JMS North America Corporation
Gastroenterology & Urology · 91d
Cleared Oct 27, 2011
ALCATRON AND / OR MULTIPLE BRAND
K112222 · LYZ
Alcatron Gloves Factory
General Hospital · 86d
Cleared Oct 27, 2011
4MP COLOR LCD MONITOR, RADIFORCERX430
K112466 · LLZ
Eizo Nanao Corporation
Radiology · 62d
Cleared Oct 27, 2011
TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
K112529 · KNG
Advanced Instrumentations, Inc.
Radiology · 57d
Cleared Oct 27, 2011
21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
K112604 · LLZ
Totoku Electric Co., Ltd.
Radiology · 50d
Cleared Oct 27, 2011
VSI GUIDEWIRE
K112631 · DQX
Vascular Solutions, Inc.
Cardiovascular · 48d
Cleared Oct 27, 2011
DX-D 600
K112670 · KPR
Agfa Healthcare N.V.
Radiology · 43d
Cleared Oct 27, 2011
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
K112713 · LJT
Norfolk Medical Products, Inc.
General Hospital · 38d
Cleared Oct 27, 2011
REHASTIM 2, REHAMOVE 2
K112844 · GZI
Hasomed GmbH
Neurology · 28d