FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38737–38760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2014
DISTALOCK TIBIAL IM NAIL SYSTEM
K132830 · HSB
Dgimed Ortho, Inc.
Orthopedic · 118d
Cleared Jan 06, 2014
21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2...
K133686 · LLZ
Jvckenwood Corporation
Radiology · 35d
Cleared Jan 06, 2014
INTONEMV
K133826 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 20d
Cleared Jan 03, 2014
FMWAND FERROMAGNETIC SURGICAL SYSTEM
K130606 · HGI
Domain Surgical, Inc.
Obstetrics & Gynecology · 302d
Cleared Jan 03, 2014
WAVE 2G, SOUL
K130937 · KLW
Hansaton Akustik GmbH
Ear, Nose, Throat · 274d
Cleared Jan 03, 2014
SYNGO.VIA WEB VIEWER
K130998 · LLZ
Siemens AG Medical Solutions
Radiology · 268d
Cleared Jan 03, 2014
SIREN EPCR SUITE
K131272 · DXJ
Medusa Medical Technologies, Inc.
Cardiovascular · 245d
Cleared Jan 03, 2014
PRISMAFLEX SYSTEM 7.10
K131516 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 220d
Cleared Jan 03, 2014
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
K131880 · OVE
Spinefrontier, Inc.
Orthopedic · 192d
Cleared Jan 03, 2014
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL...
K132399 · JFY
Elitechgroup
Chemistry · 155d
Cleared Jan 03, 2014
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
K132733 · HTN
Orthohelix Surgical Designs, Inc.
Orthopedic · 122d
Cleared Jan 03, 2014
FUSION SINGLE LINK
K132923 · KLE
Angelus Industria DE Productos...
Dental · 107d
Cleared Jan 03, 2014
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
K133146 · MSS
Bausch & Lomb
Ophthalmic · 78d
Cleared Jan 03, 2014
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2...
K133224 · MBI
Conmed Corporation
Orthopedic · 74d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Jan 03, 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM,...
K133645 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Jan 03, 2014
TRU FLU
K133714 · PSZ
Meridian Bioscience, Inc.
Microbiology · 29d
Cleared Jan 02, 2014
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
K130670 · FRO
Hydrofera, LLC
General & Plastic Surgery · 296d
Cleared Jan 02, 2014
SOMATOM DEFINITION AS OPEN
K130901 · JAK
Siemens Medical Systems, Inc.
Radiology · 276d
Cleared Jan 02, 2014
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
K131364 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 234d
Cleared Jan 02, 2014
LIGHTSCALPEL
K132661 · GEX
Lightscalpel, LLC
General & Plastic Surgery · 129d
Cleared Jan 02, 2014
SPEC MODEL M15
K132969 · KXK
Source Production & Equipment Co., Inc.
Radiology · 101d
Cleared Jan 02, 2014
GELPOINT PATH TRANSANAL ACCESS PLATFORM
K133393 · FER
Applied Medical Resources Corp.
Gastroenterology & Urology · 58d
Cleared Jan 02, 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM...
K133512 · CDD
Siemens Healthcare Diagnostics
Chemistry · 48d