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
6985–7008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2024
Kenota 1 Total IgE
K231151 · DGC
Kenota, Inc.
Immunology · 403d
Cleared May 31, 2024
Mimics Enlight CMF
K223427 · LLZ
Materialise NV
Dental · 564d
Cleared May 31, 2024
Deep TMS System
K222196 · OBP
Brainsway , Ltd.
Neurology · 679d
Cleared May 31, 2024
QIAstat-Dx Gastrointestinal Panel 2
K220062 · PCH
QIAGEN GmbH
Microbiology · 872d
Cleared May 30, 2024
SPOTFIRE RSP Pos & Neg Controls
K241289 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 23d
Cleared May 30, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
K241194 · QOF
Biofire Diagnostics, LLC
Microbiology · 30d
Cleared May 30, 2024
Spectrum Spine Cervical Cage System
K240838 · ODP
Spectrum Spine, Inc.
Orthopedic · 64d
Cleared May 30, 2024
SofWave System
K240687 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 79d
Cleared May 30, 2024
The Circadia C200 System
K234003 · DRT
Circadia Technologies, Ltd.
Cardiovascular · 163d
Cleared May 30, 2024
Freedom Wrist Arthroplasty System
K233674 · JWJ
Ascension Orthopedics, Inc.
Orthopedic · 196d
Cleared May 30, 2024
aetherSlide
K233126 · QKQ
Aetherai Co., Ltd.
Pathology · 246d
Cleared May 30, 2024
Revolution External Plating System
K233025 · KTT
New Standard Device Dba Metalogix
Orthopedic · 251d
Cleared May 30, 2024
Sunsphere
K232934 · KRD
Hangzhou Yangshun Medical Technology...
Obstetrics & Gynecology · 253d
Cleared May 30, 2024
Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
K232505 · GEI
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 286d
Cleared May 29, 2024
Arthrex TightRope II
K241235 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared May 29, 2024
SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy...
K241207 · QEW
Devoro Medical, Inc.
Cardiovascular · 29d
Cleared May 29, 2024
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe
K241190 · QNQ
Poonglim Pharmatech, Inc.
General Hospital · 30d
Cleared May 29, 2024
Temperature Sensor Probe (ABL-18TP20)
K240784 · NEY
Varian Medical Systems, Inc.
General & Plastic Surgery · 69d
Cleared May 29, 2024
InnoVoyce VYLO
K240159 · GEX
Innovoyce
General & Plastic Surgery · 131d
Cleared May 29, 2024
LINK(TM) External Fixator
K240049 · KTT
Metric Medical Devices, Inc.
Orthopedic · 142d
Cleared May 29, 2024
Lingo Glucose System
K233655 · SAF
Abbott
Chemistry · 197d
Cleared May 29, 2024
AltiVate Reverse® Glenoid
K233481 · PHX
Encore Medical, L.P.
Orthopedic · 216d
Cleared May 29, 2024
EK Digital Abutments
K233389 · NHA
Hiossen, Inc.
Dental · 240d
Cleared May 29, 2024
NET Recovery Corp/NET Device
K233166 · PZR
Net Recovery
Neurology · 245d