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

MAX 2022-12-16

Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K223153

View Details →

MWI 2022-12-15

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

Applicant Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

K-Number K221267

View Details →

LZA 2022-12-15

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs

Applicant Grand Work Plastic Products Co., Ltd.

K-Number K222892

View Details →

NFB 2022-12-15

Proxima

Applicant Dynasthetics, LLC

K-Number K220591

View Details →

DRE 2022-12-15

TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)

Applicant Spectranetics, Inc.

K-Number K223472

View Details →

LHN 2022-12-15

Small Field Applicator

Applicant Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

K-Number K220883

View Details →

LFL 2022-12-15

LOTUS Series 4 Enhanced Shears, LOTUS Series 5

Applicant Sra Developments, Ltd.

K-Number K221102

View Details →

BZQ 2022-12-15

Dozee VS

Applicant Turtle Shell Technologies Private Limited

K-Number K221555

View Details →

FXX 2022-12-15

PM Excellence SEQUR 100 Surgical Face Mask

Applicant Pm Excellence, LLC

K-Number K220520

View Details →

ELW 2022-12-15

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty

Applicant Genoss Co., Ltd.

K-Number K214086

View Details →

DZE 2022-12-15

S.I.N. Dental Implant System

Applicant S.I.N. – Sistema DE Implante Nacional S.A.

K-Number K221453

View Details →

EIA 2022-12-15

Perceptive electric dental motor and control unit

Applicant Lares Research

K-Number K220873

View Details →

Page 993 of 2738

↑