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
78505–78528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2001
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
K012435 · NGY
Bausch & Lomb, Inc.
Ophthalmic · 63d
Cleared Oct 02, 2001
SUNLITELED MODEL #2810
K012946 · EBZ
Kinetic Instruments, Inc.
Dental · 28d
Cleared Oct 02, 2001
SMARTFLOW
K012947 · DQK
Florence Medical , Ltd.
Cardiovascular · 28d
Cleared Oct 02, 2001
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
K012952 · DSY
Boston Scientific/Medi-Tech
Cardiovascular · 28d
Cleared Oct 02, 2001
COOLTOUCH VARIZOOM
K012982 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 27d
Cleared Oct 02, 2001
NEXUS 2 MODIFIED
K013008 · EMA
Sybron Dental Specialties, Inc.
Dental · 26d
Cleared Oct 02, 2001
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE...
K013104 · FPA
Sterling Medivations, Inc.
General Hospital · 15d
Cleared Oct 01, 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238 · MQB
Cares Built, Inc.
Radiology · 349d
Cleared Oct 01, 2001
CODMAN BACTISEAL CATHETERS
K003322 · HCA
Codman & Shurtleff, Inc.
Neurology · 342d
Cleared Oct 01, 2001
EXPRESSSUITE
K011049 · LMA
Vidar Systems Corp.
Radiology · 178d
Cleared Oct 01, 2001
XLTEK LED GOGGLES, MODEL LED-01
K011794 · GWE
Excel Tech. , Ltd.
Neurology · 115d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Oct 01, 2001
CYTOFLEX
K012144 · LYC
Unicare Biomedical, Inc.
Dental · 83d
Cleared Oct 01, 2001
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105,...
K012176 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 81d
Cleared Oct 01, 2001
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
K012227 · IYE
Oncology Data Systems, Inc.
Radiology · 77d
Cleared Oct 01, 2001
DOSERIGHT
K012238 · JAK
Philips Medical Systems North America...
Radiology · 76d
Cleared Oct 01, 2001
SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
K012283 · FMI
Safegard Medical Products, Inc.
General Hospital · 73d
Cleared Oct 01, 2001
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE...
K012335 · JOJ
Albert Browne , Ltd.
General Hospital · 69d
Cleared Oct 01, 2001
BAYER ADVIA SYSTEM
K012340 · JMO
Bayer Corp.
Chemistry · 69d
Cleared Oct 01, 2001
NAVIGUS II TRAJECTORY GUIDE
K012366 · HAW
Image-Guided Neurologics, Inc.
Neurology · 67d
Cleared Oct 01, 2001
BIS/EEG MODULE
K012466 · OLW
General Electric Medical Systems...
Neurology · 61d
Cleared Oct 01, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT...
K012709 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 48d
Cleared Oct 01, 2001
CTS-485 ULTRASOUND IMAGING SYSTEM
K012772 · IYO
Shantou Institute of Ultrasonic...
Radiology · 45d
Cleared Oct 01, 2001
POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
K012786 · LZA
Shamrock Manufacturing Company
General Hospital · 42d