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

Conical Platform Dental Implants System

Noris Medical , Ltd.

IntraLock System

Fusion Orthopedics, LLC

ORiGO System

Bien-Air Surgery SA

STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOC

Advanced Sterilization Products, Inc.

Primary Relief

Dyansys, Inc.

sam CS Long Duration Ultrasound Device

ZetrOZ Systems, LLC

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)

Gt Metabolic Solutions, Inc.

Disposable Monopolar Laparoscopic Tips and Reusable Handles

Dannik, LLC

Hexa-Temp

Spident Co., Ltd.

SuperBall Meniscal Repair System

Arcuro Medical , Ltd.

Intra.Ox 2.0 Handheld Tissue Oximeter

Vioptix, Inc.

BriefCase-Quantification

Aidoc Medical , Ltd.

Tegamen Nitrile Examination Gloves

M/S Tegamen Safety Products Private Limited

Embosphere Microspheres

Biosphere Medical, S.A.

VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P

Vinno Technology (Suzhou) Co.,Ltd

Terran NM-101

Terran Biosciences, Inc.

ROSA Knee System with UltraSound Imaging Platform (USIP)

Balmoral Medical, LLC

Ultrasonic Surgical System

Miconvey Technologies Co., Ltd.

APERTO Lucent MRI System

FUJIFILM Healthcare Americas Corporation

T-Edge 10, T-Edge 11

Tuttnauer , Ltd.

Annex® 2 Adjacent Level System

Spine Wave, Inc.

VirtuOst

O.N. Diagnostics

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute

Prosidyan, Inc.

SilentZPro 2.0

Shinrin-Yoku Traders, LLC

SpineSite Endoscope System

Hydrocision, Inc.

PeekMed web

Peek Health, S.A.

Medline UNITE® Medial Malleolus Peg Plate System

Medline Industries, LP

Disposable Surgical Face Mask

Shandong Zhushi Pharmaceutical Group Co., Ltd.

TECHFIT DISRP® System

Techfit Digital Surgery, Inc.

Surgical Face Mask

Hubei Yi-Ya Protective Products Co., Ltd.

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