Search FDA 510(k) Devices

5,517 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
2425–2448 of 3,225
Cleared Apr 07, 2025
Tyto Insights for Rhonchi Detection
K243567 · PHZ
Tyto Care , Ltd.
Anesthesiology · 140d
Cleared Apr 07, 2025
E-PEN (E-PEN)
K243143 · QAI
Bomtech Electronics Co., Ltd.
General & Plastic Surgery · 189d
Cleared Apr 07, 2025
LED Therapy Mask (MN1, M226)
K242385 · OHS
Shenzhen Borria Technology Co., Ltd.
General & Plastic Surgery · 238d
Cleared Apr 04, 2025
AllTest Multi-Drug Rapid Urine Test Cup
K250727 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 24d
Cleared Apr 04, 2025
Passeo-35 Xeo Peripheral Dilatation Catheter
K250706 · LIT
Biotronik, Inc.
Cardiovascular · 25d
Cleared Apr 04, 2025
DeGen Medical Patient Specific Implant (PSI) System
K250667 · MAX
Degen Medical
Orthopedic · 30d
Cleared Apr 04, 2025
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
K250656 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 30d
Cleared Apr 04, 2025
Virage® OCT Spinal Fixation System
K250332 · NKG
Highridge Medical, LLC
Orthopedic · 58d
Cleared Apr 04, 2025
Turbett Surgical Instrument Pod (TS1500)
K250011 · FRG
Turbett Surgical
General Hospital · 92d
Cleared Apr 04, 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
K243786 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 116d
Cleared Apr 04, 2025
QFR (3.0)
K243769 · QHA
Qfr Solutions BV
Radiology · 119d
Cleared Apr 04, 2025
LiquID .051 LP Guide Catheter Extension
K243691 · DQY
Seigla Medical, Inc.
Cardiovascular · 129d
Cleared Apr 04, 2025
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
K243581 · FMI
Terumo Europe N.V.
General Hospital · 141d
Cleared Apr 04, 2025
JETi Hydrodynamic Thrombectomy System
K243549 · QEZ
Abbott Medical
Cardiovascular · 140d
Cleared Apr 04, 2025
WHOOP ECG (electrocardiogram) Feature (1.0)
K243236 · QDA
Whoop., Inc.
Cardiovascular · 176d
Cleared Apr 04, 2025
Spectrum Spine Lumbar Cage System
K243074 · MAX
Spectrum Spine, Inc.
Orthopedic · 189d
Cleared Apr 04, 2025
HeartFocus (V.1.1.1)
K242807 · QJU
Deski
Radiology · 199d
Cleared Apr 04, 2025
VentStar Resus heated (N) (MP17030)
K242769 · BTL
Draegerwerk AG & CO Kgaa
Anesthesiology · 203d
Cleared Apr 04, 2025
AllTest Viral Transport Medium
K242576 · JSM
Hangzhou AllTest Biotech Co., Ltd.
Microbiology · 218d
Cleared Apr 04, 2025
UASure II Blood Uric Acid Monitoring System
K242209 · PTC
Apex BioTechnology Corp.
Chemistry · 249d
Cleared Apr 04, 2025
EyeBOX EBX-4.1
K242116 · QEA
Oculogica, Inc.
Neurology · 259d
Cleared Apr 04, 2025
TRIOS Ready Tip
K242103 · NBL
3Shape TRIOS A/S
Dental · 260d
Cleared Apr 04, 2025
LED Light Therapy Mask (RT01)
K242068 · OLP
Ningbo Dechang Electrical Machinery...
General & Plastic Surgery · 263d
Cleared Apr 04, 2025
Philips VSC-MEDlib
K242001 · BZQ
Philips Medical Systems Nederland B.V.
Anesthesiology · 269d