510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Eonis SCID-SMA Kit
Perkinelmer, Inc.
3D-RD-S
Radiopharmaceutical Imaging and Dosimetry, LLC
AIROS 6P Sequential Compression Device
Airos Medical, Inc.
Vision Monitor- MonCvONE
Metrovision
LINQ II Insertable Cardiac Monitor (LNQ22)
Medtronic, Inc.
SENSOSEEG Depth Electrodes
Sensomedical Labs, Ltd.
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/
Thermo Fisher Scientific
Technozym ADAMTS13 Activity
Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM
Profoject Disposable Needle
CMT Health PTE., Ltd.
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
Stryker GmbH
DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder);
Kamemizu Chemical Industry Co., Ltd.
TEMP MASTER, PMMA-based dental resin
Taiwan Dental Materials Co., Ltd.
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR1
Hunan Endoso Life Technology Co., Ltd.
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekt
Elekta Solutions AB
KLS Martin Pure Pectus System
KLS-Martin L.P.
SimPro Now, GentleCath Hydrophilic
Dentsply Sirona
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q G
Stryker Leibinger GmbH & Co KG
QIAstat-Dx GI Panel 2 Mini B
QIAGEN GmbH
Ultrasound Transducer Cover
Vitrolife Sweden AB
VizMark Preloaded Tissue Marker Device (VM-0001)
Breast-Med, Inc.
Quantra QStat Cartridge
Hemosonics, LLC
Microdent Sterilization Cassette
Implant Microdent System S.L.U.
Total Flow Medical Femoral Arterial (TFA) cannula
Total Flow Medical Limited
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
Nxstage Medical, Inc.
Cleaner Plus Thrombectomy System
Argon Medical Devices, Inc.
Spinal System
Teslake, Inc.
Axis Anterior Cervical Plate System
Southern Medical (Pty) , Ltd.
OptiVu ROSA® MxR
Orthosoft Inc (D/B/A Zimmer Cas)
PureLift Pro Max
Xtreem Pulse, LLC
Digital ClarusScope System; Digital NeuroPEN System
Clarus Medical, LLC
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