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

Diode laser hair removal machine (QDTM-02)

Beijing Nubway S&T Co., Ltd.

Electric Scooter (Mojo-T330)

Dongguan Smarfody Mobility Technology Co., Ltd.

Assisted Reproduction Laser System (Model ILS-400M)

Hua Yue Medical Technology Co., Ltd.

Ready to use Nelaton Catheter

Jamjoom Fullcare Corporation

SOLIUS PRO UVB Light Panel

Solius Labs, Inc.

Wellead Ureteral Catheter

Well Lead Medical Co., Ltd.

AcQMap High Resolution Imaging and Mapping System

Acutus Medical, Inc.

Telemetry Monitor 5500 Release 4.0 (867232)

Philips Medizin Systeme Böblingen GmbH

OsteoCentric Dental Implant System

OsteoCentric Technologies

SIGNA™ Bolt

Ge Medical Systems, LLC

Quantra QStat Cartridge

Hemosonics, LLC

F&P Airvo 3 NIV (PT311US)

Fisher & Paykel Healthcare, Ltd.

Profoject™ Enteral Feeding Syringe

CMT Health PTE., Ltd.

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)

Sanhe Laserconn Tech Co., Ltd.

CardiaMend Pericardial and Epicardial Reconstruction Matrix

Helios Cardio, Inc.

SOFIA 88 Catheter

MicroVention, Inc.

T-FIT

Techwin Co., Ltd.

CorVision® (91-205-Z0014)

CorVent® Medical, Inc.

Celerity™ 20 HP Biological Indicator

STERIS Corporation

ProMIS Extension Rod System

Premia Spine, Ltd.

Boehringer Laboratories Liver Retractor

Boehringer Laboratories, LLC

Iconic Nitrile Glove

Iconic Medicare Sdn Bhd

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrat

Ever Global (Vietnam) Enterprise Corporation

Digital Radiography CXDI-Elite, Digital Radiography E1

Canon, Inc.

Cove Putty, OsteoCove Putty

SeaSpine Orthopedics Corporation

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232);

Becton Dickinson

ATTUNE® Revision Cones

Depuy Ireland UC

Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom

Wontech Co., Ltd.

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Zeus Scientific

Alinity m BKV

Abbott Molecular, Inc.

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