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

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176,076 results
59209–59232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2007
AURORA LED SERIES SURGICAL LIGHTS
K071698 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 15d
Cleared Jul 06, 2007
PILLAR PEDICLE SCREW SYSTEM
K071743 · MNI
The 4th Column, LLC
Orthopedic · 9d
Cleared Jul 05, 2007
ATRICURE BIPOLAR SYSTEM
K043579 · OCL
AtriCure, Inc.
Cardiovascular · 919d
Cleared Jul 05, 2007
PRESSIO ICP MONITORING SYSTEM
K062584 · GWM
Sophysa SA
Neurology · 307d
Cleared Jul 05, 2007
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317 · LFY
Zeus Scientific, Inc.
Microbiology · 153d
Cleared Jul 05, 2007
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97,...
K070663 · EFB
A-Dec, Inc.
Dental · 118d
Cleared Jul 05, 2007
CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
K070811 · MUH
Dexco
Radiology · 101d
Cleared Jul 05, 2007
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA...
K070983 · PSV
Olympus Medical Systems Corporation
Radiology · 90d
Cleared Jul 05, 2007
POWDER-FREE VINYL EXAMINATION GLOVES
K071022 · LYZ
Glormed Colombia S.A.
General Hospital · 85d
Cleared Jul 05, 2007
LIFE LATCH SHARPS & BIOHAZARD CONTAINER
K071088 · FMI
M&M Industries, Inc.
General Hospital · 78d
Cleared Jul 05, 2007
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
K071113 · GZI
Restorative Therapies, Inc.
Neurology · 76d
Cleared Jul 05, 2007
DIGITAL STEREOLOC II
K071542 · IZH
Lorad, A Hologic Co.
Radiology · 30d
Cleared Jul 05, 2007
STIFFER COAXIAL MICRO-INTRODUCER KIT
K071574 · DYB
Enpath Medical, Inc.
Cardiovascular · 27d
Cleared Jul 05, 2007
GE OEC ALTITUDE
K071717 · IZI
Shimadzu Corp.
Radiology · 13d
Cleared Jul 03, 2007
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
K062377 · NBW
Medapps, Inc.
Chemistry · 322d
Cleared Jul 03, 2007
AOS UNIVERSAL CONECTING GUIDE TUBE
K062824 · JAQ
Alpha-Omega Services, Inc.
Radiology · 286d
Cleared Jul 03, 2007
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
K063063 · FRO
Medical Molecular Therapuetics, LLC
General & Plastic Surgery · 270d
Cleared Jul 03, 2007
MODIFICATION TO PALOMAR LUXIR HANDPIECE
K070298 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 153d
Cleared Jul 03, 2007
LG SPERM FREEZING
K070689 · MQL
Intl., Inc.
Obstetrics & Gynecology · 112d
Cleared Jul 03, 2007
FLEX-NECK ARC CATHETER
K070730 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 110d
Cleared Jul 03, 2007
QUANTUM SPINAL SYSTEM
K070973 · NKB
Pioneer Surgical Technology
Orthopedic · 88d
Cleared Jul 03, 2007
ZIMMER SEGMENTAL SYSTEM
K070978 · KRO
Zimmer, Inc.
Orthopedic · 88d
Cleared Jul 03, 2007
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
K071155 · MQV
Science For Biomaterials
Orthopedic · 69d
Cleared Jul 03, 2007
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
K071156 · IYO
Sounmed, Inc.
Radiology · 69d