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
11737–11760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2022
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt...
K222019 · NLF
Stryker Sustainability Solutions
Anesthesiology · 149d
Cleared Dec 04, 2022
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For...
K222815 · LZA
Zibo Lanhua Medical Packaging...
General Hospital · 76d
Cleared Dec 04, 2022
Disposable Nitrile Examination Gloves
K223004 · LZA
Jiangxi Handspro Products Solutions...
General Hospital · 66d
Cleared Dec 03, 2022
truSculpt flex
K212866 · NGX
Johari Digital Healthcare Limited
Physical Medicine · 451d
Cleared Dec 03, 2022
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K222713 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 03, 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K222715 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 03, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K222720 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 02, 2022
CardioGraphe
K213465 · JAK
Arineta , Ltd.
Radiology · 400d
Cleared Dec 02, 2022
CreoDent Solidex Customized Abutment and Screw
K220390 · NHA
Creodent Prosthetics, Ltd.
Dental · 294d
Cleared Dec 02, 2022
SUREcore Plus Biopsy Instrument
K220611 · KNW
Uro-1, Inc.
General & Plastic Surgery · 274d
Cleared Dec 02, 2022
SilentZPro 2.0
K220688 · LRK
Shinrin-Yoku Traders, LLC
Dental · 269d
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