RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

3,400 total clearances

Y-Knotless™ Flex Anchors

Conmed Corporation

Q-Switched Nd:YAG Laser (SHE-LSP101-1)

Beijing Sano Laser S&T Development Co.,Ltd

IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (26

Drägerwerk AG & Co. KGaA

BACK 4

Swims America Corp

Arthrex Virtual Implant Positioning (VIP) System

Arthrex, Inc.

Simplexa COVID-19 Direct

Diasorin Molecular, LLC

CEREGLIDE 92 Intermediate Catheter

Cerenovus, Inc.

Aulisa Temperature Module (TM0002)

Taiwan Aulisa Medical Devices Technologies, Inc.

Disposable Biopsy Needle

Carbon (Shenzhen) Medical Device Co., Ltd.

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro,

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Disposable Nitrile Examination Glove

Inner Mongolia Cureguard Medical Technology Co., Ltd.

Radiance V5

Gmv Soluciones Globales Internet S.A.U.

DentMix VPS Impression Material

Innovative Product Brands, Inc.

EVA15 insufflator

Palliare , Ltd.

Progrip™ Self-Gripping Polypropylene Mesh

Sofradim Production

CustomSurg OrthoPlanner

Customsurg AG

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

Abbott Point of Care, Inc.

Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe

Medline Industries, Inc.

Tzoar 207 Negative Pressure Wound Therapy (NPWT) System

Lightstone Medical Products (Ningbo) Co, Ltd.

Endophys Blood Pressure Monitor model BPM-30

Endophys Technologies, LLC

QP-Prostate® CAD

Quibim S.L.

EMS Sculpt Machine

Shandong Huamei Technology Co., Ltd.

iRAD

Claritas Healthtech Pte, Ltd.

Extended Reservoir

Medtronic Minimed, Inc.

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

Xuzhou Kernel Medical Equipment Co., Ltd.

Fixone Biocomposite Anchor

Aju Pharm Co., Ltd.

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SP

Solco Biomedical Copany India Private Limited

SurfRider 13 Microcatheter

Kaneka Americas Holding, Inc.

PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves

O&M Halyard, Inc.

LIAISON PLEX Gram-Negative Blood Culture Assay

Luminex Corporation

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