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

Filters: Cleared only ×
175,820 results
42169–42192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2013
MULTILINK AUTOMIX
K123397 · EBF
Ivoclar Vivadent, AG
Dental · 87d
Cleared Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Jan 31, 2013
DURETTE OCULAR IMPLANT
K123764 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 55d
Cleared Jan 31, 2013
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL...
K123775 · JJY
Bio-Rad Laboratories
Chemistry · 52d
Cleared Jan 31, 2013
X4 SYSTEM
K130013 · OMC
Advanced Brain Monitoring, Inc.
Neurology · 29d
Cleared Jan 30, 2013
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
K113816 · NHA
GC America, Inc.
Dental · 400d
Cleared Jan 30, 2013
T3 DENTAL IMPLANT
K122300 · DZE
Biomet 3i
Dental · 183d
Cleared Jan 30, 2013
FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK,...
K122752 · JXN
Branan Medical Corp.
Toxicology · 145d
Cleared Jan 30, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K122928 · MQB
Rayence Co., Ltd.
Radiology · 128d
Cleared CT Jan 30, 2013
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK...
K123279 · LOX
Abbott Vascular
Cardiovascular · 100d
Cleared Jan 30, 2013
ILUMIEN OPTIS
K123369 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 90d
Cleared Jan 30, 2013
LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER
K123444 · GEI
Covidien, Formerly Valleylab, A...
General & Plastic Surgery · 83d
Cleared Jan 29, 2013
VARILIFT -C
K120603 · ODP
Wenzel Spine
Orthopedic · 336d
Cleared Jan 29, 2013
IMMUNOCAP ALLERGEN K82
K121463 · DHB
Thermo Fisher Scientific
Immunology · 257d
Cleared Jan 29, 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K122431 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 172d
Cleared Jan 29, 2013
INION CPS ORBITAL PLATES
K122890 · JEY
Inion OY
Dental · 131d
Cleared CT Jan 29, 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
K123067 · DQX
Abbott Vascular, Inc.
Cardiovascular · 120d
Cleared Jan 29, 2013
PROCEDURE REHEARSAL STUDIO
K123269 · LLZ
Simbionix , Ltd.
Radiology · 102d
Cleared Jan 29, 2013
A-SCAN PLUS CONNECT
K123349 · IYO
Accutome, Inc.
Radiology · 90d
Cleared Jan 29, 2013
PACIFIC PLUS
K123358 · LIT
Medtronic Vascular
Cardiovascular · 90d
Cleared Jan 29, 2013
BIOGRAPH MCT FAMILY
K123737 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jan 29, 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · MUE
Hologic, Inc.
Radiology · 43d
Cleared Jan 29, 2013
GE ECHOPAC
K123894 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 42d
Cleared Jan 29, 2013
TRACTUS TISSUEMAPPER REVIEWER APPLICATION
K123901 · LLZ
Tractus Corporation
Radiology · 42d