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

Sensual Massage, Ultra Pure

Dreambrands, Inc.

Surgical Face Masks, Model: EFMDS-L50Pn BLU

Iris USA

Multitom Rax with True2scale Body Scan Option

Siemens Medical Solutions

Nuvola

Gruppo Europeo Ortodonzia Srl

Treace Medical Concepts (TMC) Plating System

Treace Medical Concepts, Inc.

Safe Secure Sterilization Pouches and Rolls

Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

Elexir

Nu Eyne Co., Ltd.

CuRAS hybrid

Classys, Inc.

SternaFuse Fixation System

Fusion Innovations, LLC

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

bioMerieux, Inc.

Polypectomy Snare

Hangzhou AGS MedTech Co., Ltd.

Bioptimal Bipolar Pacing Catheter

Bioptimal International Pte. , Ltd.

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

Ortho-Clinical Diagnostics, Inc.

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine

Rb Health (Us), LLC

ESSENZ Patient Monitor

Livanova Deutschland, GmbH

BonOs® Inject Bone Cement; NEO Pedicle Screw System™

Neo Medical SA

Evita V800, Evita V600

Draegerwerk AG & CO Kgaa

Erchonia Zerona Z-Bed

Erchonia Corporation

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system

Gbs Commonwealth Co., Ltd.

3DXR

GE Medical Systems SCS

Creo Electrosurgical System with NP1 Instrument

Creo Medical, Ltd.

EVA15 insufflator

Palliare , Ltd.

Stella

Shinhung Mst Co., Ltd.

i-STAT CG8+ cartridge with the i-STAT 1 System

Abbott Point of Care, Inc.

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant

Providence Medical Technology, Inc.

CDI OneView Monitoring System

Terumo Cardiovascular Systems Corporation

Materialise TKA Guide System

Materialise NV

PRO-LITE Sterilization Tray

STERIS Corporation

Star E900 Handpiece Series

Dentalez, Inc., Stardental Division

KHEIRON® Spinal Fixation System, including patient specific K-ROD

S.M.A.I.O

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