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
67009–67032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2005
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · HRX
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared Jan 12, 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 30d
Cleared Jan 12, 2005
DURAGEN II DURAL REGENERATION MATRIX
K043427 · GXQ
Integra Lifesciences Corp.
Neurology · 30d
Cleared Jan 12, 2005
CYNERGY LASER
K043429 · GEX
Cynosure, Inc.
General & Plastic Surgery · 30d
Cleared Jan 12, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 12, 2005
WILLI GELLER CREATION II PORCELAIN
K043468 · EIH
Jensen Int'L, Inc.
Dental · 27d
Cleared Jan 12, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473 · KWP
Stryker Spine
Orthopedic · 27d
Cleared Jan 12, 2005
SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K043559 · IYN
Sonosite,Inc.
Radiology · 16d
Cleared Jan 11, 2005
INBODY, MODEL 3.0
K042528 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 116d
Cleared Jan 11, 2005
ENDO TWINN
K042870 · EKM
Endo Twinn B.V.
Dental · 85d
Cleared Jan 11, 2005
VOXAR 3D PRODUCT FAMILY
K043194 · LLZ
Voxar Limited
Radiology · 54d
Cleared Jan 11, 2005
WILLI GELLER CREATION ZI PORCELAIN
K043201 · EIH
Jensen Industries, Inc.
Dental · 54d
Cleared Jan 11, 2005
MODIFICATION TO SOAKER CATHETER
K043456 · BSO
I-Flow Corp.
Anesthesiology · 27d
Cleared Jan 11, 2005
CZR PRESS LF
K043462 · EIH
Noritake Co., Inc.
Dental · 27d
Cleared Jan 11, 2005
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K043563 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared Jan 10, 2005
GOODKNIGHT H20, MODEL M-114600-00
K042184 · BTT
Mallinckrodt Developpement France
Anesthesiology · 151d
Cleared Jan 10, 2005
CYTOVISION FOR CEP XY
K042542 · NTH
Applied Imaging Corp.
Hematology · 112d
Cleared Jan 10, 2005
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K042624 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 105d
Cleared Jan 10, 2005
DENALI SPINE SYSTEM
K042635 · KWP
K2m, LLC
Orthopedic · 105d
Cleared Jan 10, 2005
VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
K042657 · MUD
Vioptix, Inc.
Cardiovascular · 104d
Cleared Jan 10, 2005
HERMES BOND 2
K043043 · KLE
3M Espe AG Dental Products
Dental · 67d
Cleared Jan 10, 2005
ONLINE DAT PHENCYCLIDINE PLUS
K043305 · LCM
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Jan 10, 2005
MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
K043354 · DRT
Invivo Research, Inc.
Cardiovascular · 35d
Cleared Jan 10, 2005
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR
K043376 · ITI
Home Health Technology Co., Ltd.
Physical Medicine · 33d