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
56905–56928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2008
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
K070889 · CGZ
Wallac OY
Chemistry · 381d
Cleared Apr 14, 2008
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
K072201 · MNR
Compumedics Limited
Anesthesiology · 250d
Cleared Apr 14, 2008
IRSG I-MOVER FOR BEDS
K072598 · FPO
International Retail Services Group, LLC
General Hospital · 213d
Cleared Apr 14, 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · LBS
Medica Corp.
Chemistry · 123d
Cleared Apr 14, 2008
PASSIVE WASTE GAS SCAVENGER, MODEL 14600
K080039 · CBN
G. Dundas Co.,Inc.
Anesthesiology · 98d
Cleared Apr 14, 2008
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
K080308 · LYC
Bioscaffold International Pte, Ltd.
Dental · 69d
Cleared Apr 14, 2008
TACAHE PC1350 POWER WHEELCHAIR
K080373 · ITI
Dalton Medical Corp.
Physical Medicine · 62d
Cleared Apr 11, 2008
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
K072460 · DQX
Abbott Vascular, Inc.
Cardiovascular · 224d
Cleared Apr 11, 2008
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
K072720 · FGE
Alveolus, Inc.
Gastroenterology & Urology · 199d
Cleared Apr 11, 2008
RESCUE INTERNAL IMPLANT SYSTEM
K073058 · DZE
Megagen Co., Ltd.
Dental · 164d
Cleared Apr 11, 2008
UNIFAST III
K073106 · EBG
GC America, Inc.
Dental · 161d
Cleared Apr 11, 2008
PHILIPS ECG ALGORITHM
K073376 · LOS
Philips Medical Systems
Cardiovascular · 130d
Cleared Apr 11, 2008
ANGIOTECH CVC
K073520 · FOZ
Angiotech Pharmaceuticals, Inc.
General Hospital · 119d
Cleared Apr 11, 2008
INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7
K073710 · DRG
Intouch Technologies
Cardiovascular · 102d
Cleared Apr 11, 2008
LIFE+CEL OR LIFECEL BATTERY
K073716 · MKJ
Amco International Manufacturing &...
Cardiovascular · 102d
Cleared Apr 11, 2008
CORAMATE/SPIROTOME SYSTEM
K080095 · KNW
Medinvents
Gastroenterology & Urology · 88d
Cleared Apr 11, 2008
DIO PROTEM IMPLANT SYSTEM
K080126 · DZE
Dio Department Dsi, Inc.
Dental · 85d
Cleared Apr 11, 2008
COMPOSITE ALIGNER BUTTON
K080246 · NXC
Dentsply Interntional
Dental · 71d
Cleared Apr 11, 2008
IMPULSE IQ ADJUSTING INSTRUMENT
K080261 · LXM
Neuromechanical Innovations, LLC
Physical Medicine · 70d
Cleared Apr 11, 2008
NAVSTATIONIRAD EMT, VERSION 1.1
K080624 · JAK
Cas Innovations AG
Radiology · 37d
Cleared Apr 11, 2008
ULTRATEMP FIRM, FAST AND REGULAR SET
K080768 · EMA
Ultradent Products, Inc.
Dental · 24d
Cleared Apr 11, 2008
CEREC OPTI SPRAY
K080882 · ELW
Sirona Dental Systems GmbH
Dental · 11d
Cleared Apr 11, 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · DPS
Medtechs, LLC
Cardiovascular · 11d
Cleared Apr 11, 2008
BRIGHTVIEW VCT IMAGING SYSTEM
K080927 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 9d