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
60001–60024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2007
TR BAND
K070423 · DXC
Terumo Medical Corp.
Cardiovascular · 43d
Cleared Mar 28, 2007
MODIFICATION TO HEALTH BUDDY APPLIANCE
K070543 · DRG
Health Hero Network, Inc.
Cardiovascular · 30d
Cleared Mar 28, 2007
MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
K070712 · GCJ
Surgical Innovations Group Plc
General & Plastic Surgery · 14d
Cleared Mar 27, 2007
MOORLD12-B1 LASER DOPPLER BURNS IMAGER
K060976 · DPT
Moor Instruments, Ltd.
Cardiovascular · 351d
Cleared Mar 27, 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
K063090 · IZQ
Medrad, Inc.
Cardiovascular · 168d
Cleared Mar 27, 2007
MONARCH III IOL DELIVERY SYSTEM
K063155 · KYB
Alcon Manufacturing, Ltd.
Ophthalmic · 161d
Cleared Mar 27, 2007
CUTERA ER:YSGG LASER HANDPIECE
K063867 · GEX
Cutera, Inc.
General & Plastic Surgery · 88d
Cleared Mar 27, 2007
CUTERA ER:YAG LASER HANDPIECE
K070138 · GEX
Cutera, Inc.
General & Plastic Surgery · 70d
Cleared Mar 27, 2007
ECG CABLES, TRUNK AND PATIENT LEAD WIRES
K070232 · DSA
American I.V. Products, Inc.
Cardiovascular · 62d
Cleared Mar 27, 2007
DIGORA PCT/DIGIPOD
K070304 · MUH
Soredex Palodex Group OY
Radiology · 55d
Cleared Mar 27, 2007
CERNER PROVISION WORKSTATION
K070394 · LLZ
Cerner Corp.
Radiology · 46d
Cleared Mar 27, 2007
MODIFICATION TO: OCU-FILM TIP COVER
K070534 · HKY
Reichert, Inc.
Ophthalmic · 29d
Cleared Mar 26, 2007
BANANA RIBBED
K063401 · HIS
Medtech Products , Ltd.
Obstetrics & Gynecology · 137d
Cleared Mar 26, 2007
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
K063442 · EZL
Degania Silicone , Ltd.
Gastroenterology & Urology · 132d
Cleared Mar 26, 2007
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
K063770 · OAT
Alpha-Bio Tec , Ltd.
Dental · 96d
Cleared Mar 26, 2007
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
K063864 · POV
Medical Electronic Systems , Ltd.
Hematology · 87d
Cleared Mar 26, 2007
ZIRBLANK-PS AND ZIRBLANK-FS
K070045 · EIH
Acucera, Inc.
Dental · 81d
Cleared Mar 26, 2007
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
K070169 · HRS
KLS-Martin L.P.
Orthopedic · 67d
Cleared Mar 26, 2007
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K070404 · LZA
Tangshan Luxiong Plastic Products...
General Hospital · 42d
Cleared Mar 26, 2007
DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE
K070407 · FXX
Dukal Corp.
General Hospital · 42d
Cleared Mar 26, 2007
REVOLIX 120
K070476 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 34d
Cleared Mar 26, 2007
ACUSON X150 ULTRASOUND SYSTEM
K070576 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Mar 26, 2007
FLEX AND LOOP COIL SET 1.5 T
K070629 · MOS
Siemens Medical Solutions
Radiology · 19d
Cleared Mar 23, 2007
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
K061412 · JFY
Thermo-Electron Corp.
Chemistry · 305d