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
10417–10440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2023
FAQ 101
K222012 · PAY
Foreo, Inc.
General & Plastic Surgery · 271d
Cleared Apr 05, 2023
Intermittent nelaton catheter for single use
K222677 · EZD
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 211d
Cleared Apr 05, 2023
Optimos™ Cystotome
K223256 · KNS
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 166d
Cleared Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
K223310 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 159d
Cleared Apr 05, 2023
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor,...
K223630 · MXD
Medtronic, Inc.
Cardiovascular · 121d
Cleared Apr 05, 2023
Da Vinci SP Surgical System (SP1098)
K230033 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Apr 05, 2023
BioSci™ Disposable Virus Sampling Tubes
K230035 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 90d
Cleared Apr 05, 2023
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
K230107 · OHT
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 82d
Cleared Apr 05, 2023
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
K230336 · OAP
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 57d
Cleared Apr 05, 2023
T-FIX™ 3DSI Joint Fusion System
K230689 · OUR
Cutting Edge Spine, LLC
Orthopedic · 23d
Cleared Apr 04, 2023
Reprocessed NRG Transseptal Needle
K213584 · QLZ
Innovative Health, LLC
Cardiovascular · 508d
Cleared Apr 04, 2023
BRM Digitalis Spacer
K220142 · KYJ
Brm Extremities Srl
Orthopedic · 441d
Cleared Apr 04, 2023
NeuroStar Advanced Therapy System (Version 3.7)
K230029 · OBP
Neuronetics
Neurology · 90d
Cleared Apr 04, 2023
Ballancer Platinum (1222)
K230385 · IRP
Mego Afek
Physical Medicine · 49d
Cleared Apr 03, 2023
G7, Dental Operative Unit and Accessories
K213749 · EIA
Shinhung Company, Ltd.
Dental · 489d
Cleared Apr 03, 2023
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile...
K220454 · NAM
Avation Medical, Inc.
Gastroenterology & Urology · 410d
Cleared Apr 03, 2023
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
K221802 · QBD
Mawi Dna Technologies
Microbiology · 286d
Cleared Apr 03, 2023
Sclerotherapy & Endoscopic Needles
K222006 · FBK
G-Flex Europe Sprl
Gastroenterology & Urology · 270d
Cleared Apr 03, 2023
M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore...
K222865 · KNW
Canyon Medical, Inc.
General & Plastic Surgery · 193d
Cleared Apr 03, 2023
Annalise Enterprise CTB Triage Trauma
K223240 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 165d
Cleared Apr 03, 2023
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall...
K230028 · JOW
Cardinal Health200, LLC
Cardiovascular · 89d
Cleared Apr 02, 2023
SpO2 Extension Cable
K222370 · DSA
Beijing Rongrui-Century Science &...
Anesthesiology · 240d
Cleared Apr 01, 2023
Maxtec MaxO2 ME+p
K221734 · CCL
Maxtec, LLC
Anesthesiology · 290d
Cleared Apr 01, 2023
FiberTak Suture Anchor
K230568 · MBI
Arthrex, Inc.
Orthopedic · 31d