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
Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE54
Bausch and Lomb
InkSpace Imaging Pediatric Body Array
Inkspace Imaging, Inc.
da Vinci Force Feedback Instruments
Intuitive Surgical, Inc.
ARROW Short Stem Humeral System
FH Industrie
MSS - Humeral reverse liners extension
Medacta International, SA
AutoContour (RADAC V5)
Radformation, Inc.
Klaxon (Twist); Klaxon (Twist R)
Klaxon Mobility GmbH
Frax 1940 for Nordlys and Frax Pro
Candela Corporation
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Garmin ECG App
Garmin International, Inc.
TANDEM Hip System
Smith & Nephew, Inc.
multiFlux 1000 (F00012408)
Fresenius Medical Care Renal Therapies Group, LLC
ONE Male Condom
Global Protection Corp.
CT Cardiomegaly
Innolitics, LLC
LibAirty Airway Clearance System
Synchrony Medical , Ltd.
IntraOp Alignment System; CONTOUR3D Bending System
Alphatec Spine, Inc.
Natural Cycles
Natural Cycles Nordic AB
Diode laser therapy device
Beijing Star New Tech Co., Ltd.
Power Wheelchair (N5515A, N5516, N5517A, N5519)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
UroNav 4
Philips DS North America, LLC
Lumen 155-SF
Intricon Corporation
Voyant Fine Fusion Device (EB230)
Applied Medical
DentaTOOTH
Asiga Pty, Ltd.
BriefCase
Aidoc Medical , Ltd.
Scivita 4KINSIGHT ICG Imaging System
Scivita Medical Technology Co., Ltd.
Single-use Surgical Mask
Taiwan Seafood and Fish Corporation
Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics, Inc.
SubtleREFORMAT (1.x)
Subtle Medical, Inc.
JLK-CTP
JLK, Inc.
Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFl
Pulnovo Medical (Wuxi) Co., Ltd.
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