Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

NCX 2021-12-20

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

Applicant Zoll Circulation, Inc.

K-Number K213031

View Details →

OMP 2021-12-20

3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)

Applicant 3M Healthcare Business Group

K-Number K211521

View Details →

NHI 2021-12-20

First Relief

Applicant Dyansys, Inc.

K-Number K212859

View Details →

LYZ 2021-12-20

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Applicant Liao Ning Shangwei Medical Products Co., Ltd.

K-Number K211865

View Details →

JWY 2021-12-20

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml

Applicant Thermo Fisher Scientific

K-Number K203741

View Details →

DXC 2021-12-20

TR BAND Radial Compression Device

Applicant Terumo Medical Corporation

K-Number K213531

View Details →

OTM 2021-12-20

AdVance XP Male Sling System

Applicant Boston Scientific Corporation

K-Number K211847

View Details →

QIH 2021-12-20

EchoGo Core (2.0)

Applicant Ultromics Limited

K-Number K213275

View Details →

ODP 2021-12-20

Vy Spine ClariVy Cervical IBF System

Applicant Vy Spine, LLC

K-Number K212715

View Details →

NLG 2021-12-20

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

Applicant Innovative Health, LLC

K-Number K212776

View Details →

LZC 2021-12-20

AspenMed+

Applicant Aspen Glove Sdn. Bhd.

K-Number K213076

View Details →

KCT 2021-12-20

TCAT TKA Instrument Tray

Applicant THINK Surgical, Inc.

K-Number K203468

View Details →

Page 1186 of 2685

↑