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
6865–6888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2024
Bioceramic Root Repair Material (C-Root BP)
K240365 · KIF
Beijing C-Root Dental Medical Devices...
Dental · 94d
Cleared May 10, 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader...
K240276 · NEZ
Given Imaging Ltd. (D.B.A. Medtronic)
Gastroenterology & Urology · 100d
Cleared May 10, 2024
HyperSuture Extension Line
K234079 · GAT
Threadstone, LLC
General & Plastic Surgery · 140d
Cleared May 10, 2024
Oocyte Flushing & Retrieval Medium
K234023 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 142d
Cleared May 10, 2024
pureFLOW 402 (F00012067)
K233950 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d
Cleared May 10, 2024
APERTO Lucent MRI System
K233629 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 179d
Cleared May 10, 2024
Filter Needle for Single Use
K233277 · FPB
Hangzhou Qiantang Longyue...
General Hospital · 224d
Cleared May 10, 2024
QIAstat-Dx® Respiratory Panel Plus
K233100 · QOF
QIAGEN GmbH
Microbiology · 227d
Cleared May 10, 2024
Aerogen®Solo Nebulizer System
K232507 · CAF
Aerogen, Ltd.
Anesthesiology · 266d
Cleared May 10, 2024
Disposable infusion set with needle
K232475 · FPA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 268d
Cleared May 10, 2024
SmartChest
K232410 · QFM
Milvue
Radiology · 274d
Cleared May 09, 2024
Flexible Fixation Device for Gynecological Applicators (GM11001960)
K240495 · JAQ
Varian Medical Systems, Inc.
Radiology · 79d
Cleared May 09, 2024
Access BR Monitor
K240403 · MOI
Beckman Coulter, Inc.
Immunology · 90d
Cleared May 09, 2024
Tulsa Pro System (Pad-105)
K240296 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 98d
Cleared May 09, 2024
Customized Abutment
K234112 · NHA
Arum Dentistry Co., Ltd.
Dental · 134d
Cleared May 09, 2024
CEREGLIDE 92 Catheter System
K233982 · QJP
Cerenovus, Inc.
Neurology · 143d
Cleared May 09, 2024
DePuy Synthes MatrixSTERNUM Fixation System
K233967 · HRS
Synthes GmbH
Orthopedic · 146d
Cleared May 09, 2024
Dental Barrier and Sleeves
K233918 · PEM
Yongqing Huaguan Dental Instruments...
Dental · 148d
Cleared May 09, 2024
P200TE (A10700)
K233602 · OBO
Optos Plc.
Ophthalmic · 182d
Cleared May 09, 2024
Biofourmis Everion+ (G2)
K233418 · MSX
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 212d
Cleared May 09, 2024
VUZE System
K232976 · LLZ
Vuze Medical , Ltd.
Radiology · 231d
Cleared May 09, 2024
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
K232477 · HGX
Jiangxi AOV Maternity & Baby Products...
Obstetrics & Gynecology · 267d
Cleared May 09, 2024
Polyisoprene Extra Large Condom
K232470 · MOL
Suretex Limited
Obstetrics & Gynecology · 267d
Cleared May 09, 2024
SC Medica FFX
K232468 · MRW
Sc Medica
Orthopedic · 268d