Search FDA 510(k) Database

Cleared Feb 16, 2023

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker...

K212194 · HAW

Stryker Corporation

Neurology · 582d

Cleared Feb 16, 2023

Surgical Gown

K213844 · FYA

Bayteks Teknik Tekstil San. VE Tic. A.S.

General Hospital · 434d

Cleared Feb 16, 2023

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X

K220698 · IOR

Panthera AB

Physical Medicine · 344d

Cleared Feb 16, 2023

Single-use Video Pancreaticobiliary Scope, PB Digital Controller

K221784 · FBN

Micro-Tech (Nanjing) Co., Ltd.

Gastroenterology & Urology · 240d

Cleared Feb 16, 2023

Passeo-35 Xeo Peripheral Dilatation Catheter

K222065 · LIT

Biotronik, Inc.

Cardiovascular · 218d

Cleared Feb 16, 2023

Disposable Infusion Bag for Parenteral Nutrition

K222622 · KPE

Beijing L&Z Medical Technology...

General Hospital · 169d

Cleared Feb 16, 2023

uMR 680

K222755 · LNH

Shanghai United Imaging Intelligence...

Radiology · 157d

Cleared Feb 16, 2023

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

K223028 · JAK

Shanghai United Imaging Healthcare...

Radiology · 140d

Cleared Feb 16, 2023

JAWS Nitinol Staple System

K223056 · JDR

Paragon 28, Inc.

Orthopedic · 139d

Cleared Feb 16, 2023

Sterile Aesthetic Cannula and Hypodermic Needle

K223327 · FMI

Shanghai Kindly Enterprise...

General Hospital · 108d

Cleared Feb 16, 2023

PMMA Blocks for Dental Use

K223477 · EBG

Aidite (Qinhuangdao) Technology Co.,...

Dental · 90d

Cleared Feb 16, 2023

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

K223478 · LON

bioMerieux, Inc.

Microbiology · 90d

Cleared Feb 16, 2023

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

K223524 · OHT

Morlaser Shenzhen Co., Ltd.

General & Plastic Surgery · 85d

Cleared Feb 16, 2023

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

K223733 · DQK

Biosense Webster, Inc.

Cardiovascular · 65d

Cleared Feb 16, 2023

NUVISION™ NAV Ultrasound Catheter

K223766 · OBJ

Biosense Webster, Inc.

Cardiovascular · 63d

Cleared Feb 16, 2023

Sonopet 1Q 3 7cm 1Q Large

K223770 · LFL

Stryker Corporation

General & Plastic Surgery · 63d

Cleared Feb 16, 2023

Vivid S60N, Vivid S70N

K223832 · IYN

Ge Medical System Ultrasound and...

Radiology · 56d

Cleared Feb 16, 2023

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

K230118 · HWC

Field Orthopaedics Pty, Ltd.

Orthopedic · 30d

Cleared Feb 15, 2023

LIGHTSCALPEL LS-4020

K213669 · GEX

Lightscalpel, Inc.

General & Plastic Surgery · 450d

Cleared Feb 15, 2023

Tanning Lamp

K221523 · LEJ

Unilam Co., Ltd.

General & Plastic Surgery · 265d

Cleared Feb 15, 2023

Altis Single Incision Sling System

K221874 · PAH

Coloplast A/S

Gastroenterology & Urology · 232d

Cleared Feb 15, 2023

Verisafe Safety sterile needles

K222271 · FMI

Promisemed Hangzhou Meditech Co., Ltd.

General Hospital · 201d

Cleared Feb 15, 2023

ZEUS System

K222389 · DQK

iRhythm Technologies, Inc.

Cardiovascular · 191d

Cleared Feb 15, 2023

Arm Blood Pressure Monitor

K222869 · DXN

Andon Health Co, Ltd.

Cardiovascular · 146d