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
18505–18528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2020
Medical Mask
K201729 · FXX
Zhende Medical Co., Ltd.
General Hospital · 162d
Cleared Dec 03, 2020
Braces on Demand Bracket
K201940 · DYW
Braces on Demand, Inc.
Dental · 143d
Cleared Dec 03, 2020
TempTraq
K201977 · FLL
Blue Spark Technologies, Inc.
General Hospital · 140d
Cleared Dec 03, 2020
aprevo Intervertebral Body Fusion Device
K202034 · MAX
Carlsmed, Inc.
Orthopedic · 133d
Cleared Dec 03, 2020
Magic UCLA Abutment System
K202418 · NHA
Innobiosurg Co., Ltd.
Dental · 101d
Cleared Dec 03, 2020
NobelProcera Zirconia Implant Bridge
K202452 · NHA
Nobel Biocare AB
Dental · 98d
Cleared Dec 03, 2020
CombiDiagnost R90
K203087 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 51d
Cleared Dec 03, 2020
NuVasive ACP System
K203253 · KWQ
Nu Vasive, Incorporated
Orthopedic · 29d
Cleared Dec 03, 2020
LineSider™ Spinal System
K203367 · NKB
Integrity Implants, Inc.
Orthopedic · 17d
Cleared Dec 02, 2020
Planmeca Romexis
K200572 · LLZ
Planmeca Oy
Radiology · 272d
Cleared Dec 02, 2020
NuVasive Navigation.S Instruments
K200719 · OLO
Nu Vasive, Incorporated
Orthopedic · 258d
Cleared Dec 02, 2020
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
K201072 · KYI
Ensemble Orthopedics, LLC
Orthopedic · 224d
Cleared Dec 02, 2020
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K202270 · KCT
K1 Medical, LLC
General Hospital · 113d
Cleared Dec 02, 2020
Palm Care Blue Nitrile Examination Gloves Powder Free
K202384 · LZA
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 104d
Cleared Dec 02, 2020
WAVICIDE-OPA MEC Indicator
K202565 · JOJ
Serim Research Corporation
General Hospital · 89d
Cleared CT Dec 02, 2020
Auryon Atherectomy System
K202835 · MCW
Eximo Medical, Ltd.
Cardiovascular · 68d
Cleared Dec 02, 2020
SMS Cementless Stem
K203041 · LZO
Medacta International S.A.
Orthopedic · 57d
Cleared Dec 02, 2020
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit...
K203053 · LNH
Canon Medical Systems Corporation
Radiology · 56d
Cleared Dec 02, 2020
Lux 35 Detector
K203159 · MQB
Carestream Health
Radiology · 40d
Cleared Dec 01, 2020
SLIMUS
K192970 · PKT
Hironic Co., Ltd.
General & Plastic Surgery · 405d
Cleared Dec 01, 2020
AcQMap High Resolution Imaging and Mapping System
K201015 · DQK
Acutus Medical, Inc.
Cardiovascular · 228d
Cleared Dec 01, 2020
Z5-TL
K201712 · DZE
Z-Systems AG
Dental · 161d
Cleared Dec 01, 2020
BASE4 Disposable Medical Mask
K202069 · FXX
Base4 Group, Inc.
General Hospital · 127d
Cleared Dec 01, 2020
Palm Care Latex Examination Powder Free Gloves
K202377 · LYY
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 103d