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

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Yung Sheng Optical Co., Ltd.

Single-use Ureteral Access Sheath

Hunan Vathin Medical Instrument Co., Ltd.

XERO-alpha

DRTECH Corporation

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Coch

Cochlear

Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Critical Care Suite with Endotracheal Tube Positing AI algorithm

Ge Medical Systems, LLC

BE Plus PRO, Neurotravel LIGHT

Eb Neuro S.P.A.

Insignia™ Anterior Cervical Plate System

Alphatec Spine, Inc.

ONE Nitrile Condom

Global Protection Corp.

Synthetic Nitrile Examination Gloves

Shandong Hongxin Chemicals Co., Ltd.

GEM Premier ChemSTAT

Instrumentation Laboratory CO

AtriCure cryoICE BOX (ACM)

AtriCure, Inc.

Actively Trying Personal Lubricant Rose Scented

CC Wellness, LLC

R3 Large Head Liners

Smith & Nephew, Inc.

OGmend® Implant Enhancement System

Woven Orthopedic Technologies

Solero Microwave Tissue Ablation (MTA) System and Accessories

AngioDynamics, Inc.

Stryker MP, Mandible, HMMF and MMF AXS Screws

Stryker Leibinger GmbH & Co KG

Catalys™ Precision Laser System

Amo Manufacturing USA, LLC

Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

Shenzhen Changkun Technology Co., Ltd.

AQUAbase nX

B.Braun Medical, Inc.

SnugFit ASA Extension

Medacta International S.A.

Clarius Prostate AI

Clarius Mobile Health Corp.

SmoothSkin Pure Unplugged (SSB3)

Cyden Limited

Imbio PHA (4.0.0)

Imbio, Inc.

Medical Surgical Mask

Nanchang Kanghua Health Materials Co., Ltd.

Zener® (model ZEN-001-B1)

Uvx, Inc.

medilogFD

Schiller AG

Surgical Face Mask

Shanghai Yunqing Industrial Co., Ltd.

Multi-Unit DAS System

Talladium España, SL

SIMDA Abutment

Simda Co., Ltd.

← PrevPage 85 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert