RecallHawk

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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