Search FDA 510(k) Database

Cleared Nov 07, 2019

Salem Sump Dual Lumen Stomach Tube with ENFit Connection

K190923 · PIF

Cardinalhealth

Gastroenterology & Urology · 212d

Cleared Nov 07, 2019

MEDIP PRO

K191026 · LLZ

Medical IP Co., Ltd.

Radiology · 203d

Cleared Nov 07, 2019

DemeDIOX Barbed Absorbable Surgical Suture

K191361 · NEW

Demetech Corporation

General & Plastic Surgery · 170d

Cleared Nov 07, 2019

SandShark Injectable Anchor (SIA) System

K191466 · GZB

Stimwave Technologies, Inc.

Neurology · 157d

Cleared Nov 07, 2019

Progenikine Concentrating System 25 mL System

K191564 · MUU

Emcyte Corporation

General & Plastic Surgery · 147d

Cleared Nov 07, 2019

Portux CAD/CAM Disc

K192153 · EBG

New Stetic, SA

Dental · 90d

Cleared Nov 07, 2019

PRECICE Plating System

K192181 · KTT

Nuvasive Specialized Orthopedics, Inc.

Orthopedic · 87d

Cleared Nov 07, 2019

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile

K192327 · HRS

Synthes USA Products, LLC

Orthopedic · 72d

Cleared Nov 07, 2019

DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless

K192632 · MQB

Canon, Inc.

Radiology · 45d

Cleared Nov 07, 2019

B. anthracis Real-time PCR Assay

K192871 · NHT

Centers For Disease Control and...

Microbiology · 30d

Cleared Nov 07, 2019

Laparoscope Lens Shield Device (LENS)

K192891 · GCJ

Medeon Biodesign, Inc.

General & Plastic Surgery · 28d

Cleared Nov 07, 2019

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G,...

K192948 · KNW

Bard Peripheral Vascular, Inc.

General & Plastic Surgery · 20d

Cleared Nov 06, 2019

Silicone Foley Catheter

K182463 · EZL

Biosensors International Pte, Ltd.

Gastroenterology & Urology · 422d

Cleared Nov 06, 2019

BIO-RAY A-1 Anchor Screw System

K182929 · OAT

Microware Precision Co., Ltd.

Dental · 380d

Cleared Nov 06, 2019

Vivid Aligners

K190003 · NXC

Orthodent Laboratory, Inc.

Dental · 308d

Cleared Nov 06, 2019

Hydrofera Blue READY - Border

K190268 · FRO

Hydrofera, LLC

General & Plastic Surgery · 271d

Cleared Nov 06, 2019

GSP Neonatal Total Galactose kit

K190335 · JIA

Perkinelmer, Inc.

Chemistry · 265d

Cleared Nov 06, 2019

Arthrex Nano SwiveLock Suture Anchor

K191651 · HWC

Arthrex, Inc.

Orthopedic · 139d

Cleared Nov 06, 2019

SOMATOM X.cite

K191891 · JAK

Siemens Medical Solutions USA, Inc.

Radiology · 114d

Cleared Nov 06, 2019

Thermo Scientific Sensititre ARIS HiQ System

K191914 · LRG

Thermo Fisher Scientific

Microbiology · 112d

Cleared Nov 06, 2019

Thermo Scientific Sensititre ARIS HiQ System

K191918 · LRG

Thermo Fisher Scientific

Microbiology · 111d

Cleared Nov 06, 2019

Conformis Hip System

K192198 · LPH

Conformis, Inc.

Orthopedic · 85d

Cleared Nov 06, 2019

Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin...

K192729 · JWY

Thermo Fisher Scientific

Microbiology · 40d

Cleared Nov 05, 2019

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head

K183457 · LPH

Zimmer, Inc.

Orthopedic · 327d