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
313–336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2026
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens...
K260507 · LPL
INTEROJO, Inc.
Ophthalmic · 101d
Cleared May 29, 2026
LASEmaR 1500
K260489 · GEX
Eufoton S.R.L.
General & Plastic Surgery · 105d
Cleared May 29, 2026
Injection Needle
K260262 · FBK
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 121d
Cleared May 29, 2026
LUNE PureHygiene
K260138 · GEX
Enamel Pure
Dental · 133d
Cleared May 29, 2026
OrthoGrid Hip AI® 4.0
K260077 · QIH
OrthoGrid Systems, Inc.
Radiology · 137d
Cleared May 29, 2026
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005,...
K254300 · HGX
Anker Innovations Limited
Obstetrics & Gynecology · 149d
Cleared May 29, 2026
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
K254076 · FCM
C.R. Bard, Inc.
Gastroenterology & Urology · 162d
Cleared May 29, 2026
CoSense ETCO Monitor
K253119 · CCJ
Capnia, Inc.
Anesthesiology · 247d
Cleared May 29, 2026
Nexus DRF Digital X-ray Imaging System
K253103 · JAA
Varex Imaging Corporation
Radiology · 247d
Cleared May 29, 2026
Oxygen Concentrator (OX-5A, OX-5C)
K252965 · CAW
Oxytek Medical Technology Co., Ltd.
Anesthesiology · 254d
Cleared May 29, 2026
HistoSonics® Planning Tool
K252947 · QTZ
HistoSonics, Inc.
Radiology · 256d
Cleared May 29, 2026
ZEUS Platform (FG0501US)
K252859 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared May 29, 2026
M12 Telemetry System
K252840 · MHX
Global Instrumentation, LLC
Cardiovascular · 266d
Cleared May 29, 2026
Reusable Adult SpO2 Clip Sensor (3m) (M1196A)
K252821 · DQA
Philips Medizin Systeme B?blingen GmbH
Anesthesiology · 267d
Cleared May 29, 2026
Peak Flow Meter (PF-10(BR-PEF231))
K252802 · BZH
Shenzhen Bi-Rich Medical Devices Co.,...
Anesthesiology · 268d
Cleared May 29, 2026
Cryo Sport 2.0 (AVA 501)
K252396 · IRP
Avanutri Equipamentos DE Saúde
Physical Medicine · 302d
Cleared May 28, 2026
ANDI 2.2
K261405 · QIH
Imeka Solutions, Inc.
Radiology · 29d
Cleared May 28, 2026
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
K261037 · IZI
Stryker Endoscopy
General & Plastic Surgery · 59d
Cleared May 28, 2026
Ulike Clear Zero (YC10 BU)
K260895 · NFO
Guangxi Ulike Medical Technology Co.,...
Neurology · 71d
Cleared May 28, 2026
Disposable Endoscopic Distal Attachments
K260423 · FDF
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 108d
Cleared May 28, 2026
Helio Kids
K260295 · IOR
Motion Composites
Physical Medicine · 119d
Cleared May 28, 2026
BD BACTEC FXI Culture System
K260213 · MDB
Bd Diagnostic Systems
Microbiology · 125d
Cleared May 28, 2026
Bellalun 2D (VDMS-1000S)
K254092 · MUE
Vieworks Co., Ltd.
Radiology · 160d
Cleared May 28, 2026
Arthrex Bioabsorbable PushLock Suture Anchors
K253931 · MAI
Arthrex, Inc.
Orthopedic · 170d