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
12049–12072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2023
WatchPAT ONE (WP1)
K223675 · MNR
Itamar Medical , Ltd.
Anesthesiology · 30d
Cleared Jan 06, 2023
U by Kotex® Click® Unscented Menstrual Tampons
K223749 · HEB
Kimberly Clark Corporation
Obstetrics & Gynecology · 23d
Cleared Jan 05, 2023
Ax-Surgi Surgical Hemostat
K213198 · POD
Advamedica, Inc.
General & Plastic Surgery · 463d
Cleared Jan 05, 2023
U-Motion II Acetabular System-Extension line
K221149 · LZO
United Orthopedic Corporation
Orthopedic · 260d
Cleared Jan 05, 2023
Treace Medical Concepts (TMC) Plating System
K221181 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 255d
Cleared Jan 05, 2023
Cervical Spine Truss System (CSTS) Interbody Fusion Device
K221266 · ODP
4Web Medical, Inc.
Orthopedic · 248d
Cleared Jan 05, 2023
Safety Push Button Blood Collection Set
K222834 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 107d
Cleared Jan 05, 2023
REMEDY Stemmed Knee Spacer
K223650 · JWH
Osteoremedies, LLC
Orthopedic · 30d
Cleared Jan 05, 2023
CONDUIT LLIF Straight Inserters
K223671 · MAX
Enztec Limited
Orthopedic · 29d
Cleared Jan 04, 2023
OnyxCeph
K213263 · LLZ
Image Instruments GmbH
Dental · 461d
Cleared Jan 04, 2023
SilentCloud
K221125 · KLW
Aureliym GmbH
Ear, Nose, Throat · 261d
Cleared Jan 04, 2023
Steriking LT-Blueline Pouches with Tyvek
K221379 · FRG
Wipak OY
General Hospital · 237d
Cleared Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
K221693 · MZO
Roche Diagnostics
Microbiology · 208d
Cleared Jan 04, 2023
Wearable Breast Pump (Model S1DW)
K222045 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Jan 04, 2023
Radial Artery Compression Tourniquets
K222182 · DXC
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 166d
Cleared Jan 04, 2023
DEKA HELIX
K222221 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 163d
Cleared Jan 04, 2023
Surgical Face Mask
K222483 · FXX
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 140d
Cleared Jan 04, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222907 · LZA
Rmkh Glove (Cambodia) Co., Ltd.
General Hospital · 100d
Cleared Jan 04, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223411 · FYC
Xiamen Probtain Medical Techology...
General Hospital · 56d
Cleared Jan 04, 2023
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
K223635 · JBP
Sienco, Inc.
Hematology · 30d
Cleared Jan 04, 2023
SmoothCool HR System
K223685 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 26d
Cleared Jan 03, 2023
AETOS Shoulder System
K220847 · KWS
Smith & Nephew, Inc.
Orthopedic · 286d
Cleared Jan 03, 2023
Medical Disposable Face Masks
K222809 · FXX
Anqing Mayfield Medical Limited
General Hospital · 109d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 57d