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
22873–22896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2019
PROSTEP TBC Implant System
K183620 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 162d
Cleared Jun 06, 2019
ComPAS2 (Computerized Pulmonary Analysis System)
K190568 · BZG
Morgan Scientific, Inc.
Anesthesiology · 92d
Cleared Jun 06, 2019
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
K190616 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Jun 06, 2019
RIGEL PEEK Anterior Cervical Interbody Fusion System
K190618 · ODP
MiRus, LLC
Orthopedic · 87d
Cleared Jun 06, 2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable...
K190827 · HIH
Uvision360, Inc.
Obstetrics & Gynecology · 66d
Cleared Jun 06, 2019
da Vinci Handheld Camera
K191043 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 48d
Cleared Jun 06, 2019
Pure Vu System
K191220 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 30d
Cleared Jun 06, 2019
Idys ALIF TiVac
K191263 · OVD
Clariance, Sas
Orthopedic · 27d
Cleared Jun 06, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope,...
K191335 · HIH
Corinth Medtech, Inc.
Obstetrics & Gynecology · 20d
Cleared Jun 05, 2019
MINE
K180671 · EHD
Rht Co., Ltd.
Radiology · 448d
Cleared Jun 05, 2019
Corin BiPolar-i
K183114 · KWY
Corin U.S.A. Limited
Orthopedic · 208d
Cleared Jun 05, 2019
WatchPAT ONE
K183559 · MNR
Itamar Medical , Ltd.
Anesthesiology · 167d
Cleared Jun 05, 2019
Low Dose Lung Screening Option
K190505 · JAK
Canon Medical Systems Corporation
Radiology · 96d
Cleared Jun 05, 2019
WalterLorenz Surgical Assist Arm Scope Holder
K190576 · OCV
Biomet Microfixation
General & Plastic Surgery · 91d
Cleared Jun 05, 2019
Biocode Gastrointestinal Pathogen Panel (GPP)
K190585 · PCH
Applied BioCode, Inc.
Microbiology · 91d
Cleared Jun 05, 2019
Signature ONE System
K190595 · KWT
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 90d
Cleared Jun 05, 2019
HydroCision TenJet Device
K190804 · HRX
Hydrocision, Inc.
General & Plastic Surgery · 68d
Cleared Jun 05, 2019
Materialise Mimics Enlight
K190874 · LLZ
Materialise NV
Radiology · 62d
Cleared Jun 05, 2019
Palm Bladder Scanner - PBSV5.1
K191307 · IYO
Mianyang Meike Electronic Equipment...
Radiology · 22d
Cleared Jun 04, 2019
Unity Total Knee System
K183533 · JWH
Corin U.S.A. Limited
Orthopedic · 167d
Cleared Jun 04, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183535 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared Jun 04, 2019
Vanguard XP Knee System
K190068 · JWH
Zimmer, Inc.
Orthopedic · 140d
Cleared Jun 04, 2019
PDS Barbed Suture, PDO MAXX Threads
K190245 · NEW
Pdo Max, Inc.
General & Plastic Surgery · 118d
Cleared Jun 04, 2019
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
K190461 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 98d