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
38089–38112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2014
VARIOGUIDE DRILL KIT
K132436 · HBE
Mri Interventions, Inc.
Neurology · 227d
Cleared Mar 20, 2014
CAIR DRIVE, NEUTRACLEAR
K133073 · FPA
Cair Lgl
General Hospital · 171d
Cleared Mar 20, 2014
ZIRTOUGH
K133211 · EIH
Kuraray Noritake Dental, Inc.
Dental · 153d
Cleared Mar 20, 2014
DIGORA OPTIME
K133231 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 150d
Cleared Mar 20, 2014
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
K133319 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 143d
Cleared Mar 20, 2014
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K133398 · MQN
Stryker
Dental · 134d
Cleared Mar 20, 2014
CAMBER SPINE COVERIS CERVICAL CAGE
K133529 · ODP
Camber Spine
Orthopedic · 125d
Cleared Mar 20, 2014
INTRA-LOCK DENTAL IMPLANTS
K133613 · DZE
Intra-Lock International, Inc.
Dental · 115d
Cleared Mar 20, 2014
TYBER MEDICAL TRAUMA SCREW
K133842 · HWC
Tyber Medical, LLC
Orthopedic · 92d
Cleared Mar 20, 2014
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
K133958 · BSZ
Maquet Critical Care AB
Anesthesiology · 86d
Cleared Mar 20, 2014
CAMBER SPINE DIAGON OBLIQUE CAGE
K134038 · MAX
Camber Spine
Orthopedic · 79d
Cleared Mar 20, 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX...
K140253 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Mar 20, 2014
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
K140465 · NQN
Ventana Medical Systems, Inc.
Pathology · 24d
Cleared Mar 19, 2014
METALLIC INTRAMEDULLARY NAIL SYSTEM
K132078 · HSB
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 257d
Cleared Mar 19, 2014
SRS ENDOSCOPIC STAPLING SYSTEM
K132151 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 251d
Cleared Mar 19, 2014
MELYS ATRIAL FIBRILLATION SCREENING MONITOR
K132206 · DXH
Advanced Fluidics, LLC
Cardiovascular · 246d
Cleared Mar 19, 2014
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
K133144 · PGK
Crossbay Medical, Inc.
Obstetrics & Gynecology · 153d
Cleared Mar 19, 2014
CIRRUS PHOTO
K133217 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 152d
Cleared Mar 19, 2014
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
K133374 · KWP
Pioneer Surgical Technology, Inc....
Orthopedic · 138d
Cleared Mar 19, 2014
SEAL SINGLE-USE BIOPSY VALVE
K133734 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 100d
Cleared Mar 19, 2014
SPEED XL
K133780 · JDR
Biomedical Ent., Inc.
Orthopedic · 97d
Cleared Mar 19, 2014
IVUE 500
K133892 · HLI
Optovue, Inc.
Ophthalmic · 89d
Cleared Mar 19, 2014
EMBOL-X INTRODUCER SHEATH
K140398 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Mar 18, 2014
ELECTRONIC THERMOMETER
K131210 · FLL
Shenzhen Pump Medical System Co., Ltd.
General Hospital · 323d