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
37609–37632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2014
NXSTAGE PUREFLOW SL
K140571 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 70d
Cleared May 15, 2014
SALVATION BEAMS AND BOLTS SYSTEM
K140741 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 51d
Cleared May 15, 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared May 15, 2014
6VT-D ULTRASOUND TRANSDUCER
K141093 · ITX
Ge Vingmed Ultrasound AS
Radiology · 17d
Cleared May 14, 2014
QUICKSCREEN AMPHETINE 500 TEST
K131069 · DKZ
Phamatech, Inc.
Toxicology · 392d
Cleared May 14, 2014
NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
K132653 · KWQ
Neoortho Productos Orthopedicos S/A
Orthopedic · 261d
Cleared May 14, 2014
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
K133046 · KKY
Matrix Surgical Holdings, LLC/Matrix...
General & Plastic Surgery · 229d
Cleared May 14, 2014
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153 · MNH
Spinefrontier, Inc.
Orthopedic · 209d
Cleared May 14, 2014
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
K133620 · OAS
Imaging Sciences International
Radiology · 170d
Cleared May 14, 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY...
K133700 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 162d
Cleared May 14, 2014
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO...
K133912 · MQL
Origio A/S
Obstetrics & Gynecology · 142d
Cleared May 14, 2014
STOP U (PACKED BLACK USA)
K140255 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 103d
Cleared May 14, 2014
SALVATION OSTEOPENIC SCREW
K140408 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared May 14, 2014
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
K140591 · ONB
Becton, Dickinson & CO
General Hospital · 68d
Cleared May 14, 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604 · MBI
ArthroCare Corporation
Orthopedic · 65d
Cleared May 14, 2014
MSP METATARSAL SHORTENING SYSTEM
K140724 · HRS
Nextremity Solutions, Inc.
Orthopedic · 54d
Cleared May 14, 2014
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV...
K141010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d
Cleared May 13, 2014
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC...
K130080 · JHY
Medica Corporation
Chemistry · 484d
Cleared May 13, 2014
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)
K132899 · ONB
Equashield Medical , Ltd.
General Hospital · 239d
Cleared May 13, 2014
BIOMARC COAXIAL NEEDLE
K133148 · FBK
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 208d
Cleared May 13, 2014
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM
K133206 · MUH
Zuma Dental, LLC
Radiology · 208d
Cleared May 13, 2014
VERSACUT + TISSUE MORCELLATOR
K133272 · GCJ
Lumenis, Ltd.
Obstetrics & Gynecology · 201d
Cleared May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
K133317 · NRY
Penumbra, Inc.
Neurology · 197d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR
K140056 · MQB
Rayence Co., Ltd.
Radiology · 123d