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
9673–9696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2023
Nooance Led And Laser Helmet
K231321 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 84d
Cleared Jul 31, 2023
BD Respiratory Viral Panel for BD MAX™ System
K230956 · QOF
Bd Integrated Diagnostic Solutions /
Microbiology · 118d
Cleared Jul 31, 2023
QUATERA 700
K230858 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 124d
Cleared Jul 31, 2023
ZENEX Implant System_Narrow
K230630 · DZE
Izenimplant Co., Ltd.
Dental · 146d
Cleared Jul 31, 2023
Disposable Hemoclip
K230004 · PKL
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 209d
Cleared Jul 31, 2023
CNS-2101 Central Monitor
K223567 · MSX
Nihon Kohden Corporation
Cardiovascular · 244d
Cleared Jul 31, 2023
RenaNav Ureteroscope System
K223097 · FGB
CenterPoint Systems, LLC
Gastroenterology & Urology · 304d
Cleared Jul 31, 2023
Surgical Sutures with or without Needle
K221767 · GAP
Huaian Seamen Medical Technology Co.,...
General & Plastic Surgery · 409d
Cleared Jul 30, 2023
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
K222862 · GEX
Lotuxs Medtech (Suzhou) Co., Ltd.
General & Plastic Surgery · 311d
Cleared Jul 28, 2023
SI-Cure Sacroiliac Joint Fusion System
K231951 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jul 28, 2023
Adena-Zina Spinal System
K231931 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 28d
Cleared Jul 28, 2023
3 Layer Surgical Mask (134252531)
K231618 · FXX
Original Mattress Factory, Inc.
General Hospital · 56d
Cleared Jul 28, 2023
Blood Tubing Lines for Hemodialysis AV06C-E
K231589 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 57d
Cleared Jul 28, 2023
Dia-Cem
K231552 · EMA
DiaDent Group International
Dental · 59d
Cleared Jul 28, 2023
Bright MTA Sealer Plus
K231480 · KIF
Genoss Co., Ltd.
Dental · 67d
Cleared Jul 28, 2023
Therapy Mask 3100 NC/SP
K231313 · BZD
Respironics, Inc.
Anesthesiology · 84d
Cleared Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI...
K231249 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 28, 2023
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
K231073 · QAI
Esthetic Medical, Inc.
General & Plastic Surgery · 105d
Cleared Jul 28, 2023
FLUOBEAM® LX Red
K230898 · QDG
Fluoptics Sas
General & Plastic Surgery · 119d
Cleared Jul 28, 2023
BlueStar and BlueStar Rx
K230813 · NDC
Welldoc, Inc.
Chemistry · 126d
Cleared Jul 28, 2023
Pathfinder Endoscope Overtube with Balloon Device
K230801 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 127d
Cleared Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
K223781 · PJD
Immunalysis Corporation
Chemistry · 224d
Cleared Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · CGA
Abbott Point of Care, Inc.
Chemistry · 228d
Cleared Jul 28, 2023
MESI mTablet ECG Diagnostic System, MESI mTablet ECG
K223670 · DPS
Mesi, Development of Medical Devices,...
Cardiovascular · 233d