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
23929–23952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2019
Study Watch
K182456 · DXH
Verily Life Sciences, LLC
Cardiovascular · 132d
Cleared Jan 17, 2019
CervAlign™ Anterior Cervical Plate System
K183060 · KWQ
Pioneer Surgical Technology, Inc....
Orthopedic · 76d
Cleared Jan 17, 2019
VIVA combo RF System
K183538 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 29d
Cleared Jan 16, 2019
Disposable Ultra Reinforced Surgical Gown
K173847 · FYA
Xiantao Rayxin Medical Products Co.,...
General Hospital · 393d
Cleared Jan 16, 2019
Dosis SAM
K180410 · MQS
Dosis, Inc.
Gastroenterology & Urology · 336d
Cleared Jan 16, 2019
SIRA RFA Electrosurgical Device
K181071 · GEI
Innoblative Designs, Inc.
General & Plastic Surgery · 268d
Cleared Jan 16, 2019
Powder Free Nitrile Patient Examination Gloves, Blue Color
K181106 · LZA
Jiangsu Dongxin Medical Technology...
General Hospital · 265d
Cleared Jan 16, 2019
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS...
K181451 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 229d
Cleared Jan 16, 2019
Estremo Citieffe Nailing System
K181540 · HSB
Citieffe S.R.L.
Orthopedic · 219d
Cleared Jan 16, 2019
4CIS® Pinehurst Anterior Cervical Plate system
K182489 · KWQ
Solco Biomedical Co., Ltd.
Orthopedic · 127d
Cleared Jan 16, 2019
Merit RadialFlo Arterial Catheter
K182538 · FOZ
Merit Medical Singapore Pte. , Ltd.
Cardiovascular · 124d
Cleared Jan 16, 2019
HbA1c Advanced
K182651 · PDJ
Beckman Coulter Ireland, Inc.
Chemistry · 114d
Cleared Jan 16, 2019
Pristine Scope
K183165 · HRX
Pristine Surgical
General & Plastic Surgery · 62d
Cleared Jan 16, 2019
Laser Hair Therapy
K183329 · OAP
Omm Imports, Inc. D/B/A Zero Gravity
General & Plastic Surgery · 47d
Cleared Jan 16, 2019
Carestream DRX-1 System with DRX Core Detectors
K183474 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Jan 16, 2019
T2 STRATOSPHERE Expandable Corpectomy System
K183510 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 15, 2019
Avenue P Cage System
K181096 · OVD
Zimmer Biomet Spine, Inc.
Orthopedic · 264d
Cleared Jan 15, 2019
Whistler Modular Pedicle Screw System
K182478 · NKB
Evolution Spine, LLC
Orthopedic · 127d
Cleared Jan 15, 2019
OsteoCool RF Ablation System
K182497 · GEI
Medtronic Sofamor Danek USA, Inc.
General & Plastic Surgery · 125d
Cleared Jan 15, 2019
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD...
K183497 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 29d
Cleared Jan 14, 2019
Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as...
K180570 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 315d
Cleared Jan 14, 2019
Small Bone Phantom® Intramedullary Nail System
K182307 · HSB
Paragon 28, Inc.
Orthopedic · 143d
Cleared Jan 14, 2019
TenoTac Soft Tissue Fixation System
K182898 · MBI
Paragon 28, Inc.
Orthopedic · 90d
Cleared Jan 14, 2019
ZELTIQ CoolSculpting System
K183514 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 27d