Search FDA 510(k) Database

6,579 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
10369–10392 of 174,061
Cleared Dec 23, 2022
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K223565 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Dec 22, 2022
Lp(a) Ultra
K211058 · DFC
SENTINEL CH. SpA
Chemistry · 622d
Cleared Dec 22, 2022
SteriKing LT-Blueline Pouches with Tyvek
K221377 · FRG
Wipak OY
General Hospital · 224d
Cleared Dec 22, 2022
Arthrex FiberTak Suture Anchor
K221396 · MBI
Arthrex, Inc.
Orthopedic · 223d
Cleared Dec 22, 2022
PerioStom Dental Dressing
K221428 · OLR
Forward Science, LLC
General & Plastic Surgery · 220d
Cleared Dec 22, 2022
TruWave Disposable Pressure Transducer
K222216 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Dec 22, 2022
Sunrise
K222262 · QRS
Sunrise SA
Anesthesiology · 147d
Cleared Dec 22, 2022
iFuse Bedrock Granite® Implant System
K222774 · OUR
SI-BONE, Inc.
Orthopedic · 99d
Cleared Dec 22, 2022
Kodiak C Spinal Implant System
K222806 · ODP
Met One Technologies, LLC
Orthopedic · 97d
Cleared Dec 22, 2022
Invisalign System, Pre-Formed Attachment System
K222894 · NXC
Align Technology, Inc.
Dental · 90d
Cleared Dec 22, 2022
Air Compression Leg Massager (Model: LY-670D)
K222949 · IRP
Zhejiang Luyao Electronics Technology...
Physical Medicine · 86d
Cleared Dec 22, 2022
Tesera-K SC System
K223105 · OVE
Kyocera Medical Technologies, Inc.
Orthopedic · 83d
Cleared Dec 22, 2022
Coltolux Comfort LED Curing Light
K223142 · EBZ
Dent4you AG
Dental · 79d
Cleared Dec 22, 2022
ASTRA Spine System
K223273 · NKB
Spinecraft, LLC
Orthopedic · 59d
Cleared Dec 22, 2022
Philips CT 3500
K223311 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 55d
Cleared Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · OCL
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 22, 2022
Biograph Vision Quadra PET/CT System
K223547 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 22, 2022
VERTICALE® Navigation Instruments
K223649 · OLO
Silony Medical GmbH
Orthopedic · 16d
Cleared Dec 21, 2022
CURA-Temp
K202965 · EBG
Mgnewton , Ltd.
Dental · 812d
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 447d
Cleared Dec 21, 2022
BiWaze Clear System
K213564 · NHJ
Abmrc, LLC
Anesthesiology · 407d
Cleared Dec 21, 2022
DRI TM Tricyclics Serum Tox Assay
K213875 · LFH
Microgenics Corporation
Toxicology · 373d
Cleared Dec 21, 2022
Comfort Gown, Safewear Gown
K213893 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 372d
Cleared Dec 21, 2022
BresoDX1
K220012 · MNR
Bresotec, Inc.
Anesthesiology · 351d