FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
11473–11496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2022
Chemical Indicator for Steam
K220778 · JOJ
True Indicating, LLC
General Hospital · 260d
Cleared Dec 02, 2022
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
K221113 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 231d
Cleared Dec 02, 2022
PageWriter TC35 Cardiograph
K221141 · DPS
Medizin Systeme Boblingen GmbH
Cardiovascular · 227d
Cleared Dec 02, 2022
Self-Cath and Self-Cath Plus
K221401 · EZD
Coloplast
Gastroenterology & Urology · 200d
Cleared Dec 02, 2022
Maestro Platform
K221410 · FQO
Moon Surgical
General & Plastic Surgery · 200d
Cleared Dec 02, 2022
NaviCam Small Bowel Capsule Endoscopy System
K221590 · NEZ
Ankon Technologies Co., Ltd.
Gastroenterology & Urology · 183d
Cleared Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
K223072 · EOX
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Dec 02, 2022
INHANCETM Shoulder System – Humeral Stems and Stemless
K223211 · PHX
Depuy Ireland UC
Orthopedic · 46d
Cleared Dec 02, 2022
Parietene Macroporous Mesh
K223218 · FTL
Sofradim Production
General & Plastic Surgery · 46d
Cleared Dec 02, 2022
DropSafeTM SicuraTM
K223353 · FMI
Pikdare Spa
General Hospital · 30d
Cleared Dec 02, 2022
truFreeze Console, PN CC301
K223369 · GEH
STERIS Corporation
General & Plastic Surgery · 28d
Cleared Dec 01, 2022
Bolt Navigation System
K213768 · OWB
Circinus Medical Technology, LLC
Radiology · 365d
Cleared Dec 01, 2022
STAR Apollo Mapping System
K220786 · DQK
Rhythm Al, Ltd.
Cardiovascular · 259d
Cleared Dec 01, 2022
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
K221747 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 168d
Cleared Dec 01, 2022
ProBeam 360° Proton Therapy System
K221791 · LHN
Varian Medical Systems, Inc.
Radiology · 163d
Cleared Dec 01, 2022
2-Way 100% Silicone Cleartract Catheter
K222118 · EZL
Silq Technologies, Corp.
Gastroenterology & Urology · 136d
Cleared Dec 01, 2022
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D,...
K222125 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 136d
Cleared Dec 01, 2022
CentriMag Pre-connected Pack
K222297 · DTZ
Abbott
Cardiovascular · 122d
Cleared Dec 01, 2022
Chartis Precision Catheter
K222340 · CBI
Pulmonx Corporation
Anesthesiology · 120d
Cleared Dec 01, 2022
MIST IC
K222368 · NHA
Imagine Milling Technologies, LLC
Dental · 118d
Cleared Dec 01, 2022
Mercury® II Spinal System
K222516 · NKB
Spinal Elements, Inc.
Orthopedic · 104d
Cleared Dec 01, 2022
IPL Cooling Hair Removal Device
K222710 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 84d
Cleared Dec 01, 2022
Trigon™ HA Stand-Alone Wedge Fixation System
K223226 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 44d
Cleared Nov 30, 2022
Paneffort AAMI Level 3 Isolation Gown
K212717 · FYC
Paneffort, LLC
General Hospital · 460d