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
21481–21504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2019
MatriStem UBM Pericardial Patch
K191734 · PSQ
Acell, Inc.
Cardiovascular · 147d
Cleared Nov 22, 2019
SMR TT Augmented Glenoid System
K191746 · PHX
Lima Corporate S.P.A.
Orthopedic · 144d
Cleared Nov 22, 2019
Hair Growth System
K191754 · OAP
Kunshan Bella Optical Technology Co.,...
General & Plastic Surgery · 144d
Cleared Nov 22, 2019
BruxZir GT (Gum Tissue) Color
K191903 · EIH
Prismatik Dentalcraft, Inc.
Dental · 129d
Cleared Nov 22, 2019
Trevo Trak 21 Microcatheter
K192122 · DQO
Stryker
Neurology · 108d
Cleared Nov 22, 2019
AMIStem-P Short Neck
K192126 · LZO
Medacta International S.A.
Orthopedic · 108d
Cleared Nov 22, 2019
6450 Ultrasound system
K192157 · IYN
Esaote, S.P.A.
Radiology · 105d
Cleared Nov 22, 2019
Trevo NXT ProVue Retriever
K192207 · POL
Stryker
Neurology · 100d
Cleared Nov 22, 2019
Synergy Platform, Synergy, Infinity, VersaHD
K192242 · IYE
Elekta Limited
Radiology · 95d
Cleared Nov 22, 2019
everX Flow
K192260 · EBF
GC America, Inc.
Dental · 93d
Cleared Nov 22, 2019
LEva Pelvic Digital Health System
K192270 · HIR
Renovia, Inc.
Obstetrics & Gynecology · 92d
Cleared Nov 22, 2019
Navigated Anterolateral Disc Prep Instruments
K192336 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 86d
Cleared Nov 22, 2019
Medsynapse Ris Pacs & Medsynapse VNA
K192508 · LLZ
Medsynaptic Private, Ltd.
Radiology · 71d
Cleared Nov 22, 2019
Spes Medica Subdermal Needle Electrodes
K192603 · GXZ
Spes Medica Srl
Neurology · 63d
Cleared Nov 22, 2019
VariAx Foot
K192675 · HRS
Stryker GmbH
Orthopedic · 57d
Cleared Nov 22, 2019
ADVIA Centaur CA 15-3 assay
K192777 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 53d
Cleared Nov 22, 2019
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test...
K192843 · LCX
Innovita (Tangshan) Biological...
Chemistry · 50d
Cleared Nov 22, 2019
Senhance Surgical System
K192877 · NAY
Transenterix, Inc.
General & Plastic Surgery · 45d
Cleared Nov 22, 2019
Parcus Synd-EZ SS
K192964 · MBI
Parcus Medical, LLC
Orthopedic · 30d
Cleared Nov 22, 2019
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
K193017 · MQB
DRTECH Corporation
Radiology · 24d
Cleared Nov 22, 2019
EXPD 4343P, EXPD 3643P
K193031 · MQB
DRTECH Corporation
Radiology · 23d
Cleared Nov 22, 2019
C2 CryoBalloon EndoGrip
K193036 · OCX
Pentax Medical, A Division of Pentax...
General & Plastic Surgery · 22d
Cleared Nov 22, 2019
Hemochron Signature Elite
K193041 · JPA
Accriva Diagnostics, Inc.
Hematology · 22d
Cleared Nov 21, 2019
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K181839 · LFD
Oralabs, Inc.
Dental · 498d