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
HistoSonics® Planning Tool
HistoSonics, Inc.
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Hood (DH-083ST)
Fujifilm Corporation
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
Asahi Intecc Co., Ltd.
PRIMED Pediatric Facemask
Primed Medical Products, Inc.
ARROW Off-Centred Humeral Insert
FH Industrie
VenAir, Sequential Compression System
Apex Medical Corp.
SMR Shoulder System
Lima Corporate S.P.A.
NEXUS® Hip Stem
Microport Orthopedics, Inc.
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
Tuttnauer , Ltd.
Disposable Medical Surgical Mask
Hubei Huaqiang High-Tech Co., Ltd.
CastleLoc-P Anterior Cervical Plate System
L&K BIOMED Co., Ltd.
CiRX Single use electrosurgical pencil with non-coated and coated electrode
Ningbo Shun YE Medical Company, Ltd.
Verisafe Safety Retractable Insulin Syringes
Promisemed Hangzhou Meditech Co., Ltd.
Zavation Spinal System
Zavation Medical Products, LLC
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
REDEMPTION Beaming System
Vilex, LLC
Durex Patronus Wide
Rb Health (Us), LLC
Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics
Penumbra LP Coil System
Penumbra, Inc.
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
Ids, Limited
Arrow 0.2 Micron Flat Filter, GVS
Arrow International, LLC
ARTAssistant
Manteia Technologies Co., Ltd.
Open Rib
Canon Medical Informatics, Inc.
CROSSLEAD Penetration Peripheral Guide Wire
Asahi Intecc Co., Ltd.
Spirair Nasal Septal Strap
Spirair, Inc.
Neteera 130H-Plus Vital Sign Monitoring Sensor
Neteera Technologies , Ltd.
Clungene RSV Antigen Rapid Test
Hangzhou Clongene Biotech Co., Ltd.
Single-use Sterile High-pressure Angiographic Syringes and Accessories
Shenzhen Boon Medical Supply Co., Ltd.
Fogg System Patient Monitoring Cables
Fogg System Company, Inc.
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