Search FDA 510(k) Devices

5,520 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
2833–2856 of 174,061
Cleared May 12, 2025
P-Cure Proton Therapy System (PPTS)
K242418 · LHN
P-Cure, Ltd.
Radiology · 270d
Cleared May 11, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
K250360 · NUH
Shenzhen Jiantuo Electronics Co., Ltd.
Neurology · 90d
Cleared May 10, 2025
Flowflex Plus COVID-19 + Flu A/B Home Test
K250377 · SCA
ACON Laboratories, Inc.
Microbiology · 89d
Cleared May 09, 2025
turbodent touch
K251425 · KOJ
Mectron S.P.A.
Dental · 1d
Cleared May 09, 2025
SKOUT system
K251126 · QNP
Iterative Health
Gastroenterology & Urology · 28d
Cleared May 09, 2025
EPIQ Series Diagnostic Ultrasound Systems
K251110 · IYN
Philips Ultrasound, LLC
Radiology · 28d
Cleared May 09, 2025
VeriSight Intracardiac Echocardiography Catheter (VSICE2D)
K251103 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 28d
Cleared May 09, 2025
Electric Wheelchair (F309)
K250758 · ITI
Changshu Pingfang Wheelchair Co., Ltd.
Physical Medicine · 57d
Cleared May 09, 2025
Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
K250400 · GEI
Vigeon Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared May 09, 2025
CT/ MR Tandem and Ovoid Set
K250299 · JAQ
Varian Medical Systems, Inc.
Radiology · 98d
Cleared May 09, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
K250053 · NUH
Shenzhen Jiantuo Electronics Co., Ltd.
Neurology · 119d
Cleared May 09, 2025
Volta AF-Xplorer
K243812 · DQK
Volta Medical
Cardiovascular · 149d
Cleared May 09, 2025
Altaviz Intravitreal Syringe
K243322 · QLY
Altaviz, LLC
General Hospital · 198d
Cleared May 09, 2025
BTL-785MJ
K243290 · NUW
BTL Industries, Inc.
Dental · 203d
Cleared May 09, 2025
Second Opinion® BLE
K243230 · QIH
Pearl, Inc.
Radiology · 213d
Cleared May 09, 2025
Water Solubility Human Body Lubricant
K243107 · NUC
Dongguan Yanxuan Biotechnology Co., Ltd.
Obstetrics & Gynecology · 221d
Cleared May 09, 2025
Tristel OPH
K242732 · QWS
Tristel Solutions , Ltd.
General Hospital · 241d
Cleared May 09, 2025
SteadiSet Infusion Set
K242692 · FPA
Capillary Biomedical, LLC
Chemistry · 242d
Cleared May 09, 2025
PATH BGC
K242392 · QJP
Crossroads Neurovascular, Inc.
Neurology · 270d
Cleared May 09, 2025
LensHooke X12 PRO Semen Analysis System
K242388 · POV
Bonraybio Co., Ltd.
Hematology · 270d
Cleared May 09, 2025
DiaSys Procalcitonin FS
K242294 · PTF
Diasys Diagnostic Systems GmbH
Microbiology · 280d
Cleared May 09, 2025
Avidhrt Sense SpO2
K241086 · DQA
Avidhrt, Inc.
Cardiovascular · 385d
Cleared May 08, 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · CBK
Telesair, Inc.
Anesthesiology · 27d
Cleared May 08, 2025
COLONNADE Posterior Screw Fixation System
K250582 · NKB
CG Bio Co., Ltd.
Orthopedic · 70d