Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

QBD 2023-02-17

Spectrum Saliva Collection Device

Applicant Spectrum Solutions, LLC

K-Number K223497

View Details →

CAC 2023-02-17

FlowSaver Blood Return System

Applicant Inari Medical, Inc.

K-Number K221483

View Details →

IYE 2023-02-17

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip

Applicant Macromedics BV

K-Number K222977

View Details →

FGB 2023-02-17

Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101

Applicant STERIS Corporation

K-Number K223466

View Details →

PKT 2023-02-17

EON

Applicant Dominion Aesthetic Technologies, Inc.

K-Number K222226

View Details →

OHT 2023-02-16

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03

Applicant Morlaser Shenzhen Co., Ltd.

K-Number K223524

View Details →

LON 2023-02-16

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin

Applicant bioMerieux, Inc.

K-Number K223478

View Details →

HAW 2023-02-16

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

Applicant Stryker Corporation

K-Number K212194

View Details →

JAK 2023-02-16

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K223028

View Details →

IYN 2023-02-16

Vivid S60N, Vivid S70N

Applicant Ge Medical System Ultrasound and Primary Care Diagnostics

K-Number K223832

View Details →

OBJ 2023-02-16

NUVISION™ NAV Ultrasound Catheter

Applicant Biosense Webster, Inc.

K-Number K223766

View Details →

HWC 2023-02-16

Bony Trauma Extremity System (BTES) Screw Range, NX Nail

Applicant Field Orthopaedics Pty, Ltd.

K-Number K230118

View Details →

Page 951 of 2738

↑