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
48121–48144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2011
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
K102532 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 175d
Cleared Feb 25, 2011
NON-CONTACT INFRARED THERMOMETER
K102947 · FLL
K-Jump Health Co., Ltd.
General Hospital · 144d
Cleared Feb 25, 2011
SNORE GUARD
K103004 · LRK
Ranir, LLC
Dental · 140d
Cleared Feb 25, 2011
TOSHIBA 1.5T EXTRA LARGE KNEE COIL
K103185 · MOS
Quality Electrodynamics
Radiology · 120d
Cleared Feb 25, 2011
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · FRC
Advanced Sterilization Products
General Hospital · 116d
Cleared Feb 25, 2011
MULTIPLE NAME
K103337 · LZA
Ideal Quality Sdn., Bhd.
General Hospital · 102d
Cleared Feb 25, 2011
ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
K103397 · IYN
Medison Co., Ltd.
Radiology · 98d
Cleared Feb 25, 2011
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449 · KXK
Riverpoint Medical
Radiology · 94d
Cleared Feb 25, 2011
IPS EMPRESS DIRECT FLOW
K103528 · EBF
Ivoclar Vivadent, Inc.
Dental · 87d
Cleared Feb 25, 2011
VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
K103772 · LYZ
Advanced Medical Devices Factory
General Hospital · 60d
Cleared Feb 25, 2011
ECHELON RAPID CARDIAC COIL
K110120 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 38d
Cleared Feb 25, 2011
APPROACH PRO ST WIRE GUIDE
K110163 · DQX
Cook Incorporated
Cardiovascular · 37d
Cleared Feb 25, 2011
ENDOLOGIX GUIDEWIRE
K110241 · DQX
Techdevice Corporation
Cardiovascular · 29d
Cleared Feb 25, 2011
ESCOM 100
K110428 · EBF
Spident Co., Ltd.
Dental · 11d
Cleared Feb 24, 2011
SPECTRASHIELD 9500 SURGICAL MASK
K090414 · ONT
Nexera Medical, Inc.
General Hospital · 736d
Cleared Feb 24, 2011
PATIENT SAFE LUER CAP
K101708 · FMF
Retractable Technologies, Inc.
General Hospital · 252d
Cleared Feb 24, 2011
SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12,...
K101797 · LFL
Covidien, Formerly Valleylab, A...
General & Plastic Surgery · 241d
Cleared Feb 24, 2011
ICUFF REPAIR PLATE, RIGHT
K102539 · MBI
Shoulder Options, Inc.
Orthopedic · 174d
Cleared Feb 24, 2011
PICCOLO COMPOSITE PLATE SYSTEM
K102597 · HRS
N.M.B. Medical Applications, Ltd.
Orthopedic · 167d
Cleared Feb 24, 2011
TROPHON
K103059 · OUJ
Nanosonics Limited
General Hospital · 132d
Cleared Feb 24, 2011
BILLY BOY MALE LATEX CONDOM
K103119 · HIS
Sheila Pickering PHD
Obstetrics & Gynecology · 125d
Cleared Feb 24, 2011
SILS PORT
K103253 · GCJ
Coviden (Formerly Registered AS US...
General & Plastic Surgery · 113d
Cleared Feb 24, 2011
BHDENTAL IMPLANT SYSTEM
K103280 · NHA
Bhdental, Ltd.
Dental · 111d
Cleared Feb 24, 2011
SINGLE USE BILIARY DRAINAGE STENT V
K103478 · FGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d