Search FDA 510(k) Devices

5,426 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
937–960 of 3,225
Cleared Sep 17, 2025
Double Tube Herbst Appliance
K243752 · LRK
The Tmj Clinic PC
Dental · 286d
Cleared Sep 16, 2025
ACCUJECT Injector Set 2.1-1P (LP604590)
K252540 · MSS
Medicel AG
Ophthalmic · 35d
Cleared Sep 16, 2025
Medline Microtek C-Flo Bag Decanter, Sterile (2000S)
K251676 · LHI
Microtek Medical, LLC
General Hospital · 109d
Cleared Sep 16, 2025
Insight Enhanced™ DRF (EN-1002-01)
K251650 · JAA
Imaging Engineering, LLC
Radiology · 110d
Cleared Sep 16, 2025
SFIT Abutment
K242287 · NHA
Cowellmedi Co., Ltd.
Dental · 410d
Cleared Sep 15, 2025
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K252598 · FAJ
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 28d
Cleared Sep 15, 2025
SpaceFix Shoulder Spacer
K252443 · MBB
G21, S.R.L.
Orthopedic · 42d
Cleared Sep 15, 2025
Zener® (model ZEN-001-B1)
K252128 · FRA
Uvx, Inc.
General Hospital · 70d
Cleared Sep 15, 2025
IPL Hair Removal Device (MLY-M011)
K251914 · OHT
Miley Technology (Hebei) Co., Ltd.
General & Plastic Surgery · 84d
Cleared Sep 15, 2025
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · EGS
Premium Plus (Dongguan) Limited
Dental · 89d
Cleared Sep 15, 2025
iGPS Navigation Instruments
K251780 · OLO
SI-BONE, Inc.
Orthopedic · 97d
Cleared Sep 15, 2025
Sober Self-Test
K250609 · DIC
Sober Ip, LLC
Toxicology · 199d
Cleared Sep 15, 2025
InferOperate Suite
K250237 · QIH
Beijing Infervision Healthcare...
Radiology · 231d
Cleared Sep 14, 2025
CloudTMS Edge
K250689 · OBP
Teleemg, LLC
Neurology · 192d
Cleared Sep 13, 2025
BrainsWay Deep TMS System
K251449 · OBP
Brainsway , Ltd.
Neurology · 127d
Cleared Sep 12, 2025
Stethophone Pro
K252595 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 28d
Cleared Sep 12, 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
K252593 · MXD
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Sep 12, 2025
CADDIE
K252586 · QNP
Odin Medical Limited
Gastroenterology & Urology · 28d
Cleared Sep 12, 2025
Legend X Platform
K252576 · GEI
Pollogen, Ltd.
Neurology · 29d
Cleared Sep 12, 2025
Spine & Trauma Navigation Instruments
K252562 · OLO
Brainlab AG
Orthopedic · 29d
Cleared Sep 12, 2025
Wisdiag Multi-Drug Urine Test Cup
K252554 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared Sep 12, 2025
PowerKnot High Strength Sutures
K252225 · GAT
Medacta International S.A.
General & Plastic Surgery · 58d
Cleared Sep 12, 2025
LED Light Therapy Mask (2311, 2344, 2457, 2458)
K252189 · OHS
Dongguan Yanxi Technology Co., Ltd.
General & Plastic Surgery · 60d
Cleared Sep 12, 2025
Vertex(TM) Catheter
K252027 · DYB
Jupiter Endovascular
Cardiovascular · 74d