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
11041–11064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2023
8X-10-6XXX Camera Head
K223116 · GCJ
Santa Barbara Imaging Systems
General & Plastic Surgery · 148d
Cleared Feb 28, 2023
SurBlate Ablation System
K223272 · NEY
Mima-Pro Scientific, Inc.
General & Plastic Surgery · 127d
Cleared Feb 28, 2023
REVCON (TM) Screw System
K223392 · HWC
Voom Medical Devices, Inc.
Orthopedic · 112d
Cleared Feb 28, 2023
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06...
K223618 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 85d
Cleared Feb 28, 2023
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
K230038 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 53d
Cleared Feb 28, 2023
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System
K230245 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Feb 28, 2023
VIOLA
K230248 · DXC
Vascular Graft Solutions, Ltd.
Cardiovascular · 29d
Cleared Feb 27, 2023
Idylla MSI Test
K211181 · PZJ
Biocartis NV
Pathology · 678d
Cleared Feb 27, 2023
Milli Vaginal Dilator
K220035 · HDX
Materna Medical
Obstetrics & Gynecology · 418d
Cleared Feb 27, 2023
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
K222173 · OCX
Saneso, Inc.
Gastroenterology & Urology · 221d
Cleared Feb 27, 2023
Ogmend® Implant Enhancement System
K223075 · QVI
Woven Orthopedic Technologies
Orthopedic · 150d
Cleared Feb 27, 2023
BENCOX Mirabo Z Cup Cortinium
K223223 · LPH
Corentec Co., Ltd.
Orthopedic · 133d
Cleared Feb 27, 2023
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
K223253 · EIH
Arum Dentistry Co., Ltd.
Dental · 129d
Cleared Feb 26, 2023
Handheld Pulse Oximeter
K213431 · DQA
Shenzhen Witleaf Medical Electronics...
Anesthesiology · 493d
Cleared Feb 25, 2023
CompuFlo Epidural Computer Controlled Anesthesia System
K221702 · FMF
Milestone Scientific, Inc.
Anesthesiology · 257d
Cleared Feb 24, 2023
InnoGenic Non-resorbable Membrane
K211554 · NPK
Cowellmedi Co., Ltd.
Dental · 646d
Cleared Feb 24, 2023
MAGNETOM Vida
K213805 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 445d
Cleared Feb 24, 2023
RealNow
K213891 · LLZ
Yiwei Medical Technology Co., Ltd.
Radiology · 437d
Cleared Feb 24, 2023
AVIEW Lung Nodule CAD
K221592 · OEB
Coreline Soft Co., Ltd.
Radiology · 267d
Cleared Feb 24, 2023
TytoCare Lung Sounds Analyzer
K221614 · PHZ
Tyto Care , Ltd.
Anesthesiology · 266d
Cleared Feb 24, 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K221845 · NXC
Blue Sky Bio, LLC
Dental · 245d
Cleared Feb 24, 2023
Visionbody
K222386 · NGX
Vb Technologies AG
Physical Medicine · 200d
Cleared Feb 24, 2023
Clarus Viewer
K222757 · LLZ
Clarus Viewer Corporation
Radiology · 165d
Cleared Feb 24, 2023
Ti-Largo Cervical Interbody System
K223231 · ODP
Flospine
Orthopedic · 129d