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
54937–54960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2008
LIPOSE FAT TRANSFER SYSTEM
K081848 · MUU
Lipose Corp.
General & Plastic Surgery · 157d
Cleared Dec 04, 2008
HOLTER LX ANALYSIS
K081861 · MNR
North East Monitoring, Inc.
Anesthesiology · 156d
Cleared Dec 04, 2008
PRO GLUCOSE TEST STRIP
K082169 · NBW
Taidoc Technology Corporation
Chemistry · 125d
Cleared Dec 04, 2008
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS
K082387 · OTP
American Medical Systems
Obstetrics & Gynecology · 107d
Cleared Dec 04, 2008
DEPUY ASPHERE M-SPEC HEAD
K082585 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Dec 04, 2008
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
K082670 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Dec 04, 2008
OMNI-TIGHT
K082749 · DZE
Basic Dental Implant Systems, Inc.
Dental · 76d
Cleared Dec 04, 2008
NANOCORSS .014 OTW PTA DILATATION CATHETER
K082854 · DQY
Ev3, Inc.
Cardiovascular · 66d
Cleared Dec 04, 2008
VISION WIRE CORONARY GUIDEWIRE
K082935 · DQX
Biotronik, Inc.
Cardiovascular · 64d
Cleared Dec 04, 2008
TIVAMED COOLED RF SYSTEM, MODEL 78001
K082962 · GEI
Tivamed, Inc.
General & Plastic Surgery · 62d
Cleared Dec 04, 2008
SUINSA DIAGNOSTIC X-RAY SYSTEM
K083109 · KPR
Suinsa
Radiology · 45d
Cleared Dec 04, 2008
HEADWAY 17 MICROCATHETER
K083343 · DQY
MicroVention, Inc.
Cardiovascular · 21d
Cleared Dec 04, 2008
NUOVOCATH
K083454 · FOZ
U.S. Safety Syringes Co., Inc.
General Hospital · 13d
Cleared Dec 03, 2008
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
K081592 · LZA
Quality Gallant Sdn. Bhd.
General Hospital · 180d
Cleared Dec 03, 2008
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 167d
Cleared Dec 03, 2008
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
K082225 · GEX
Biolitec, Inc.
General & Plastic Surgery · 119d
Cleared Dec 03, 2008
VICARDIO 12B
K082380 · DPS
Energy-Lab Technologies GmbH
Cardiovascular · 106d
Cleared Dec 03, 2008
LEDEX, MODEL: WL-070
K082408 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 104d
Cleared Dec 03, 2008
NO!NO! SKIN
K082423 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 103d
Cleared Dec 03, 2008
MARK 5 NUVO LITE OCSI AND STD
K082566 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 90d
Cleared Dec 03, 2008
PULSAR GENERATOR, PEAK PLASMABLADE
K082786 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 71d
Cleared Dec 03, 2008
MERCURY SPINAL SYSTEM
K083230 · NKB
Spinal Elements, Inc.
Orthopedic · 30d
Cleared Dec 02, 2008
ZIOCERA & CONVERTIBLE SYSTEM
K081786 · NHA
Osstem Implant Co., Ltd.
Dental · 161d
Cleared Dec 02, 2008
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
K082539 · BTY
Cardinal Health Germany 234 GmbH
Anesthesiology · 91d