FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29881–29904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2017
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm...
K161616 · HWC
Synthes USA Products, LLC
Orthopedic · 248d
Cleared Feb 16, 2017
SLIT LAMP, Model: YF-100
K161764 · HJO
Chongqing Yeasn Science-Technology...
Ophthalmic · 234d
Cleared Feb 16, 2017
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
K161996 · MQV
Amend Surgical, Inc.
Orthopedic · 212d
Cleared Feb 16, 2017
STERRAD NX Sterilizer
K162007 · MLR
Advanced Sterilization Products
General Hospital · 211d
Cleared Feb 16, 2017
T-Cuff
K162365 · KCY
Terumobct, Inc.
General & Plastic Surgery · 177d
Cleared Feb 16, 2017
4CIS® Marlin ACIF Cage System
K162402 · ODP
Solco Biomedical Co., Ltd.
Orthopedic · 174d
Cleared Feb 16, 2017
RF1400 Active Compression Wrap
K162481 · JOW
Recovery Force, LLC
Cardiovascular · 163d
Cleared Feb 16, 2017
Miromatrix Biological Mesh TW
K162570 · FTM
Miromatrix Medical, Inc.
General & Plastic Surgery · 154d
Cleared Feb 16, 2017
Spine Wave Anterior Cervical Spine System
K162760 · OVE
Spine Wave, Inc.
Orthopedic · 139d
Cleared Feb 16, 2017
VitriGuard
K162833 · MQK
Origio A/S
Obstetrics & Gynecology · 128d
Cleared Feb 16, 2017
Huvex Interspinous Fixation System
K162849 · PEK
Dio Medical Co., Ltd.
Orthopedic · 128d
Cleared Feb 16, 2017
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
K162965 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 115d
Cleared Feb 16, 2017
AM-100
K163165 · NGX
BTL Industries, Inc.
Physical Medicine · 98d
Cleared Feb 16, 2017
ALLY™ Facet Screws
K163374 · MRW
Providence Medical Technology, Inc.
Orthopedic · 77d
Cleared Feb 16, 2017
Fiagon Navigation – PointerTube Straight and PointerTube Keat
K163416 · PGW
Fiagon GmbH
Ear, Nose, Throat · 73d
Cleared Feb 16, 2017
ClotTriever Thrombectomy System
K163549 · QEW
Inari Medical, Inc.
Cardiovascular · 62d
Cleared Feb 16, 2017
Kepler I Cervical Plate System
K163602 · KWQ
Orbbo Surgical, LLC
Orthopedic · 57d
Cleared Feb 16, 2017
Laparoscope Lens Shield Device (LENS)
K170103 · GCJ
Medeon Biodesign, Inc.
General & Plastic Surgery · 35d
Cleared Feb 16, 2017
Valleylab FT10 Electrosurgical Platform
K170170 · GEI
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Feb 15, 2017
PC ECG
K160876 · DPS
Edan Instruments, Inc.
Cardiovascular · 322d
Cleared Feb 15, 2017
Medela Low Dose Enteral Syringe
K161811 · PNR
Medela, Inc.
Gastroenterology & Urology · 229d
Cleared Feb 15, 2017
IBS Implant System II
K162099 · DZE
Innobiosurg Co., Ltd.
Dental · 201d
Cleared Feb 15, 2017
Abbott ARCHITECT Free T3
K170160 · JIT
Abbott Laboratories
Chemistry · 28d
Cleared Feb 14, 2017
Bashan TDP Heat Lamp
K162590 · ILY
Chogqing Yuhe Medical Instruments...
Physical Medicine · 151d