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
37873–37896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2014
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
K141204 · HRS
Stryker Trauma AG
Orthopedic · 42d
Cleared Jun 20, 2014
RADSPA
K141329 · LLZ
Telerad Tech Private Limited
Radiology · 30d
Cleared Jun 20, 2014
ECHO TIP ULTRA FIDUCIAL NEEDLE
K141356 · NEU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 28d
Cleared Jun 19, 2014
JR IMPLANT SYSTEM
K130694 · DZE
LK Consulting Group USA, Inc.
Dental · 462d
Cleared Jun 19, 2014
SILDENT
K132869 · ELW
Hrs Co., Ltd.
Dental · 279d
Cleared Jun 19, 2014
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K132891 · FRO
The Hymed Group Corp.
General & Plastic Surgery · 276d
Cleared Jun 19, 2014
ABBVIE PEG
K133087 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 262d
Cleared Jun 19, 2014
ABBVIE NJ
K133129 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 262d
Cleared Jun 19, 2014
TRUFREEZE SYSTEM
K133258 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 239d
Cleared Jun 19, 2014
DISPOSABLE PRESSURE MANOMETER
K140370 · CAP
Besmed Health Business Corp
Anesthesiology · 125d
Cleared Jun 19, 2014
MIROMATRIX WOUND MATRIX
K140510 · KGN
Miromatrix Medical, Inc.
General & Plastic Surgery · 111d
Cleared Jun 19, 2014
PROCEM
K140644 · NEA
Ototronix, LLC
Ear, Nose, Throat · 98d
Cleared Jun 19, 2014
COSMOLOCK PEDICLE SCREW SYSTEM
K140678 · MNH
Kalitec Direct, LLC
Orthopedic · 93d
Cleared Jun 19, 2014
OSSEOFLEX SB
K140937 · NDN
Osseon, LLC
Orthopedic · 69d
Cleared Jun 18, 2014
KONIX STERILE GEL
K130581 · MUI
Turkuaz Saglik Hizmetleri Medikal...
Radiology · 470d
Cleared Jun 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130733 · LYZ
Benteng Plastic Co., Ltd.
General Hospital · 457d
Cleared Jun 18, 2014
ABB VIE J
K133096 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 261d
Cleared Jun 18, 2014
QUALIS
K133295 · MQK
Menicon Co., Ltd. New Business Division
Obstetrics & Gynecology · 236d
Cleared Jun 18, 2014
QARDIOARM
K140067 · DXN
Qardio, Inc.
Cardiovascular · 159d
Cleared Jun 18, 2014
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES
K140583 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 104d
Cleared Jun 18, 2014
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · PHX
Tornier, Inc.
Orthopedic · 57d
Cleared Jun 18, 2014
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
K141313 · KRD
Reverse Medical Corporation
Cardiovascular · 29d
Cleared Jun 18, 2014
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS...
K141363 · MSD
Merit Medical Systems, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 17, 2014
ULTRA RENEW PLUS
K132833 · OLP
Accord Media
General & Plastic Surgery · 280d