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
43225–43248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2012
AQUILION ONE VISION, V4.90
K122109 · JAK
Toshiba America Medical Systems, In.C
Radiology · 66d
Cleared Sep 21, 2012
VOLUSON E6/E8/E8EXPERT/E10
K122327 · IYN
Ge Healthcare
Radiology · 51d
Cleared Sep 20, 2012
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO
K113282 · LYC
Riemser Arzeimittel AG
Dental · 318d
Cleared Sep 20, 2012
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720 · JJY
Randox Laboratories, Ltd.
Chemistry · 276d
Cleared Sep 20, 2012
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS,...
K113863 · MST
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Sep 20, 2012
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP...
K120462 · MLO
Inovise Medical, Inc.
Cardiovascular · 218d
Cleared Sep 20, 2012
CHAMP CHAMP TRANSIT
K120501 · IOR
Convaid Products, Inc.
Physical Medicine · 212d
Cleared Sep 20, 2012
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
K120867 · OLO
Medos International SARL
Orthopedic · 182d
Cleared Sep 20, 2012
METS MODULAR PROXIMAL FEMUR
K121056 · JDI
Stanmore Implants Worldwide , Ltd.
Orthopedic · 167d
Cleared Sep 20, 2012
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
K121262 · NGT
Medefil, Inc.
General Hospital · 147d
Cleared Sep 20, 2012
VESTIBULAR ANALYSIS APPARATUS
K121590 · LXV
Capacity Sports, LLC
Ear, Nose, Throat · 112d
Cleared Sep 20, 2012
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
K121676 · LNH
Ge Medical Systems, LLC
Radiology · 105d
Cleared Sep 20, 2012
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
K121724 · FCW
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 100d
Cleared Sep 20, 2012
E-CUBE 7
K121729 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 100d
Cleared Sep 20, 2012
Typhoon(TM) Facet Screw Fixation System
K121850 · MRW
Choicespine, LP
Orthopedic · 87d
Cleared Sep 20, 2012
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY...
K121926 · LZC
Northstar Healthcare Holdings
General Hospital · 80d
Cleared Sep 20, 2012
STERISPINE LC CAGE
K122021 · MAX
Safe Orthopaedics
Orthopedic · 72d
Cleared Sep 20, 2012
NEOMED ORAL/ENTERAL SYRINGE
K122373 · FMF
Neomed, Inc.
General Hospital · 45d
Cleared Sep 20, 2012
NEXTGEN ALTIUS OCT SYSTEM
K122378 · KWP
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 45d
Cleared Sep 20, 2012
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
K122541 · KTW
Orthofix Srl
Orthopedic · 30d
Cleared Sep 20, 2012
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K122545 · LJS
Arrow International (Subsidiary of...
General Hospital · 30d
Cleared Sep 20, 2012
ULTRASAFE PASSIVE NEEDLE GUARD
K122558 · MEG
Safety Syringes, Inc.
General Hospital · 29d
Cleared Sep 19, 2012
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
K120018 · HGM
Mindchild Medical
Obstetrics & Gynecology · 260d
Cleared Sep 19, 2012
ORTHOCAD SOFTWARE OPTION
K120288 · LLZ
Esaote, S.P.A.
Radiology · 232d