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
Ultrasonic Gastrovideoscope
Sonoscape Medical Corp.
SnapshotNIR model KD205
Kent Imaging, Inc.
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Revers
Gyrus Acmi, Inc.
BTL-899A
BTL Industries, Inc.
Vessel Sealer Curved (480522)
Intuitive Surgical, Inc.
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1)
Surgify Medical OY
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Elos Accurate® Hybrid Base
Elos Medtech Pinol A/S
APTUS Foot System 2.8-3.5
Medartis AG
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI
Philips Medizin Systeme Böblingen GmbH
ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
Energy Resources International Co., Ltd.
MAMMOMAT B.brilliant (11372950)
Siemens Medical Solutions USA, Inc.
BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
C.R. Bard, Inc.
TiLink-L Navigation Instruments
SurGenTec, LLC
Cumulus Functional Neurophysiology Platform
Cumulus Neuroscience Limited
RF Cannula
Shanghai Samedical & Plastic Instruments Co., Ltd.
WHOOP ECG (electrocardiogram) Feature (1.0)
Whoop., Inc.
Disposable Medical Face Mask
Xiantao Zhuobo Industrial Co., Ltd.
Safety Insulin Syringes
Berpu Medical Technology Co., Ltd.
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
Shenzhen Imdk Medical Technology Co., Ltd.
AutoContour Model RADAC V2
Radformation, Inc.
Sterilization Wrap
Kenpax International Limited
Knee+
Pixee Medical
Dental Air Polishing Handpiece
Guilin Woodpecker Medical Instrument Co., Ltd.
UltiCare Disposable Pen Needles
Ultimed Incorporated
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ort
Stryker Leibinger GmbH & Co KG
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
Dentona AG
BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx
Vivachek Biotech (Hangzhou) Co., Ltd.
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
Zhuhai Pusen Medical Technology Co., Ltd.
Passeo-35 Xeo Peripheral Dilatation Catheter
Biotronik, Inc.
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