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
EsoCheck Cell Collection Device
Lucid Diagnostics, Inc.
Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Inte
Convatec
Liposaver
Lhbiomed Co., Ltd.
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
Mytech Intelligence (Shenzhen) Co., Ltd.
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
Zimmer, Inc.
AllTest Strep A Rapid Test
Hangzhou AllTest Biotech Co., Ltd.
pVasc Net Mechanical Thrombectomy Device
Vesalio, Inc.
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
Nakanishi, Inc.
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Na
Stryker Corporation
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
STERIS Corporation
LapBox Tissue Containment Removal System
Ark Surgical, Ltd.
Elecsys EBV EBNA IgG
Roche Diagnostics
Solar Compact (G4-1)
Laborie Medical Technologies, Corp.
IPL hair removal device
Lumenessa Corp
SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Ur
Guangzhou Wondfo Biotech Co., Ltd.
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI2
Shenzhen Ulike Smart Electronics Co., Ltd.
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Picocaremajesty
Wontech Co., Ltd.
HemosIL Silica Clotting Time
Instrumentation Laboratory (IL) Co.
BPS Wrist Fracture System
Orthonovis, Inc.
CRYOcheck Chromogenic Factor IX
Precision Biologic, Inc.
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
Honsun (Nantong) Co., Ltd.
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
Gentuity, LLC
DenMat Glutaraldehyde Desensitizer
Denmat Holding, LLC
Perceptive electric dental motor and control unit
Lares Research
CraniUS Plate
CraniUS, LLC
Mobile X-ray unit (!M1)
Solutions For Tomorrow AB
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
Eco Medi Glove Sdn. Bhd.
Novalung ultimate kit (US)
Fresenius Medical Care Renal Therapies Group, LLC
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Persyst Development Corporation
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