Search FDA 510(k) Devices

5,437 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
1393–1416 of 3,129
Cleared Jul 29, 2024
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · PZX
AtriCure, Inc.
Cardiovascular · 214d
Cleared Jul 29, 2024
Medical surgical mask
K233723 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 251d
Cleared Jul 26, 2024
Symbia SPECT and SPECT/CT Systems
K241898 · KPS
Siemens Healthineers
Radiology · 28d
Cleared Jul 26, 2024
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)
K241883 · HBL
Pro-Med Instruments GmbH
Neurology · 28d
Cleared Jul 26, 2024
InnovaMatrix®FD
K241866 · KGN
Convatec Triad Life Sciences, LLC
General & Plastic Surgery · 29d
Cleared Jul 26, 2024
Introcan Safety® 2 IV Catheter
K241845 · FOZ
B.Braun Medical, Inc.
General Hospital · 30d
Cleared Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
K241800 · MRR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 26, 2024
NEXA™ NPWT System
K241515 · OMP
Nexa Medical Limited
General & Plastic Surgery · 58d
Cleared Jul 26, 2024
Pantheon Pedicle Screw and Iliac Bolt Fixation System
K241494 · NKB
Pantheon Spinal
Orthopedic · 59d
Cleared Jul 26, 2024
Alien Aligners
K241187 · NXC
Alien Milling Technologies
Dental · 88d
Cleared Jul 26, 2024
Tandem Mobi Insulin Pump with interoperable technology
K241078 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 98d
Cleared Jul 26, 2024
Luja female (20051)
K241028 · EZD
Coloplast
Gastroenterology & Urology · 102d
Cleared Jul 26, 2024
STAR Apollo™ Mapping System
K240509 · DQK
Rhythm AI, Ltd.
Cardiovascular · 155d
Cleared Jul 26, 2024
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001,...
K240401 · HIH
Origyn Medical Technology (Hangzhou)...
Obstetrics & Gynecology · 168d
Cleared Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · DRC
Synaptic Medical Corporation
Cardiovascular · 178d
Cleared Jul 26, 2024
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
K240169 · HQC
Bausch and Lomb, Incorporated
Ophthalmic · 186d
Cleared Jul 26, 2024
Resolv Endoscopic Hemostat System
K234131 · QAU
Hemostasis, LLC
General & Plastic Surgery · 211d
Cleared Jul 26, 2024
VOLT™ Proximal Humerus 3.5 Plating System
K233994 · HRS
Synthes GmbH
Orthopedic · 221d
Cleared Jul 26, 2024
Spine Navigation System
K233725 · OLO
Medivis, Inc.
Orthopedic · 248d
Cleared Jul 26, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K233530 · KPR
DRTECH Corporation
Radiology · 267d
Cleared Jul 26, 2024
“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System...
K233501 · MNR
Largan Medical Co., Ltd.
Anesthesiology · 269d
Cleared Jul 26, 2024
Vent Vial Adapter
K233287 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 301d
Cleared Jul 26, 2024
Cell-Free DNA BCT
K231776 · QMA
Streck, Inc.
Chemistry · 406d
Cleared Jul 26, 2024
EasyStat 300
K220328 · CGA
Medica Corporation
Chemistry · 903d