FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12865–12888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2022
Disposable Medical Nitrile Examination Gloves
K220237 · LZA
Fujian Jixiang Medical Technology...
General Hospital · 186d
Cleared Aug 01, 2022
Consolidated HC Steam Sterilizer
K220736 · FLE
Consolidated Machine Corp.
General Hospital · 140d
Cleared Aug 01, 2022
IPL hair removal
K221451 · OHT
Shenzhen Lizbella Technology Co.,Ltd
General & Plastic Surgery · 75d
Cleared Aug 01, 2022
X-ray Flat Panel Detectors (CareView 1800 RF)
K221549 · MQB
Careray Digital Medical Technology...
Radiology · 62d
Cleared Aug 01, 2022
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
K221616 · MHX
Caf Medical Solutions, Inc.
Cardiovascular · 59d
Cleared Aug 01, 2022
CellFX® System
K221671 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 53d
Cleared Jul 30, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For...
K221773 · LZA
Onetexx Sdn Bhd
General Hospital · 39d
Cleared Jul 29, 2022
DiviTum TKa
K202852 · QTE
Biovica International AB
Immunology · 669d
Cleared Jul 29, 2022
Tablo Hemodialysis System
K211370 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 451d
Cleared Jul 29, 2022
Bodyport Cardiac Scale
K211585 · DSB
Bodyport, Inc.
Cardiovascular · 431d
Cleared Jul 29, 2022
Medispine - Spinal Needle, Glospine - Spinal Needle
K212982 · BSP
Global Medikit Limited
Anesthesiology · 315d
Cleared Jul 29, 2022
Auxilock Titanium Screw-In Suture Anchor
K213104 · MBI
Auxein Medical Private Limited
Orthopedic · 308d
Cleared Jul 29, 2022
ABMD Software
K213760 · KGI
HeartLung Corporation
Radiology · 240d
Cleared Jul 29, 2022
Microstream CO2 NanoPod
K213911 · CCK
Covidien, LLC
Anesthesiology · 226d
Cleared Jul 29, 2022
Injection Needle
K213914 · FBK
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 226d
Cleared Jul 29, 2022
NobelProcera Zirconia N1 Base
K220048 · NHA
Nobel Biocare Services AG
Dental · 204d
Cleared Jul 29, 2022
091 Balloon Guide Catheter
K220331 · DQY
Inneuroco, Inc.
Neurology · 175d
Cleared Jul 29, 2022
Vascette HP (hemostatic pad)
K220566 · QSY
Koag, LLC
General & Plastic Surgery · 151d
Cleared Jul 29, 2022
Dental Handpiece, Model CA160, CA160L, and CA500L
K220577 · EGS
Micro-Nx Co., Ltd.
Dental · 151d
Cleared Jul 29, 2022
OptiVu ROSA MxR
K220733 · SBF
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 137d
Cleared Jul 29, 2022
S-Core Implant System
K220901 · MBI
Subchondral Solutions, Inc.
Orthopedic · 123d
Cleared Jul 29, 2022
Deep Learning Image Reconstruction
K220961 · JAK
Ge Healthcare Japan Corporation
Radiology · 119d
Cleared Jul 29, 2022
Next Generation NetKonnect
K220989 · MHX
Nihon Kohden Digital Health...
Cardiovascular · 116d
Cleared Jul 29, 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221242 · EIH
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 88d