Search FDA 510(k) Database

6,688 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12025–12048 of 174,061
Cleared Jun 23, 2022
EDEN Spinal Fixation System
K201788 · NKB
Jmt Co., Ltd.
Orthopedic · 723d
Cleared Jun 23, 2022
maxmorespine Bipolar Electrodes
K211173 · GEI
Hoogland Spine Products, GmbH
General & Plastic Surgery · 429d
Cleared Jun 23, 2022
HD Mediastinoscope
K213194 · EWY
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 267d
Cleared Jun 23, 2022
EZYPRO ECG Recorder (Model: UG02)
K213233 · DRG
Sigknow Biomedical Co., Ltd.
Cardiovascular · 266d
Cleared Jun 23, 2022
CORE-CLIP
K213338 · PKL
Incore Co., Ltd.
Gastroenterology & Urology · 259d
Cleared Jun 23, 2022
Catalyst R1 Reverse Shoulder System
K213349 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 258d
Cleared Jun 23, 2022
SYLFIRM X
K213612 · GEI
VIOL Co., Ltd.
General & Plastic Surgery · 220d
Cleared Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
K220494 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 121d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Smart Soft Healthcare AD
Radiology · 121d
Cleared Jun 23, 2022
bite away neo
K220514 · IRT
mibeTec GmbH
Physical Medicine · 121d
Cleared Jun 23, 2022
Mural Perinatal Surveillance
K220732 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 101d
Cleared Jun 23, 2022
Introcan Safety 2 IV Catheter
K220756 · FOZ
B.Braun Medical, Inc.
General Hospital · 100d
Cleared Jun 23, 2022
Ultrasound System SONIMAGE MX1
K220993 · IYN
Konica Minolta, Inc.
Radiology · 80d
Cleared Jun 23, 2022
ZEPTO Precision Capsulotomy System
K221188 · PUL
Centricity Vision, Inc.
Ophthalmic · 59d
Cleared Jun 23, 2022
Excipio SV Thrombectomy Device
K221204 · QEW
Contego Medical, Inc.
Cardiovascular · 58d
Cleared Jun 23, 2022
Axial3D Cloud Segmentation Service
K221511 · LLZ
Axial Medical Printing Limited
Radiology · 30d
Cleared Jun 22, 2022
Klassic Knee System
K211877 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 370d
Cleared Jun 22, 2022
Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711),...
K212665 · DQA
Huizhou Xiaoou Technology Co., Ltd.
Anesthesiology · 303d
Cleared Jun 22, 2022
T3 Platform Software
K213230 · PPW
Etiometry, Inc.
Cardiovascular · 266d
Cleared Jun 22, 2022
Qlicksmart BladeFlask UNIVERSAL
K213274 · MMK
Qlicksmart Pty , Ltd.
General Hospital · 265d
Cleared Jun 22, 2022
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283 · GBM
Convatec Limited
Gastroenterology & Urology · 264d
Cleared Jun 22, 2022
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced,...
K213345 · EWO
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jun 22, 2022
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
K213682 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 212d
Cleared Jun 22, 2022
Nitrile Examination Gloves
K213739 · LZA
Hangzhou Runheng Medical Co., Ltd.
General Hospital · 205d