Search FDA 510(k) Database

Cleared Dec 30, 2020

Arthrex Low Profile Screws

K203239 · HWC

Arthrex, Inc.

Orthopedic · 57d

Cleared Dec 29, 2020

XR-MX/1000

K200965 · JAA

KARL STORZ Endoscopy-America, Inc.

Radiology · 263d

Cleared Dec 29, 2020

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 &...

K202455 · IYN

Supersonic Imagine

Radiology · 124d

Cleared Dec 29, 2020

M5 Recorder

K202456 · DSH

Global Instrumentation, LLC

Cardiovascular · 124d

Cleared Dec 29, 2020

E-Cath STIM acc. Tsui

K202699 · CAZ

PAJUNK GmbH Medizintechnologie

Anesthesiology · 104d

Cleared Dec 29, 2020

First Relief v1

K202940 · QHH

Dyansys, Inc.

Neurology · 90d

Cleared Dec 29, 2020

Venue Fit

K203137 · IYN

GE Medical Systems Ultrasound and...

Radiology · 70d

Cleared Dec 29, 2020

Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever

K203219 · POL

Stryker Neurovascular

Neurology · 57d

Cleared Dec 29, 2020

BriefCase

K203508 · QAS

Aidoc Medical , Ltd.

Radiology · 29d

Cleared Dec 29, 2020

Baby Gorilla/Gorilla Plating System

K203511 · HRS

Paragon 28, Inc.

Orthopedic · 29d

Cleared Dec 28, 2020

Novaerus NV1050

K200321 · FRF

Novaerus Us, Inc.

General Hospital · 322d

Cleared Dec 28, 2020

Tailored-C Cervical Interbody Fusion System

K200458 · ODP

Bespoke Technologies

Orthopedic · 307d

Cleared Dec 28, 2020

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

K200968 · CBI

Insung Medical Co., Ltd.

Anesthesiology · 262d

Cleared Dec 28, 2020

Self-Contained Biological Indicator

K200970 · FRC

True Indicating, LLC

General Hospital · 259d

Cleared Dec 28, 2020

Uni-FuZe-P Bone Putty

K201781 · MQV

Zavation Medical Products, LLC

Orthopedic · 181d

Cleared Dec 28, 2020

Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)

K201800 · EHD

Nanoray Co., Ltd.

Radiology · 181d

Cleared Dec 28, 2020

Attune Revision Sleeve LPS Femoral Adaptors

K202248 · JWH

Depuy Ireland UC

Orthopedic · 140d

Cleared Dec 28, 2020

Smart SPACE Shoulder System

K202454 · QHE

Techmah Medical, LLC

Orthopedic · 123d

Cleared Dec 28, 2020

Quadra-P

K202730 · LZO

Medacta International S.A.

Orthopedic · 101d

Cleared Dec 28, 2020

Optiflux Series of Dialyzers F160NR, F180NR, F200NR

K203062 · KDI

Fresenius Medical Care Renal...

Gastroenterology & Urology · 80d

Cleared Dec 27, 2020

MBT Sepsityper

K193419 · QNJ

Bruker Daltonik GmbH

Microbiology · 384d

Cleared Dec 27, 2020

8-CH Electroencephalography Amplifier

K201747 · GWL

Hipposcreen Neurotech Corp.

Neurology · 184d

Cleared Dec 25, 2020

ImPACT Version 4

K202485 · POM

Impact Applications, Inc.

Neurology · 116d

Cleared Dec 24, 2020

Image Quality Analyzer (IQA)

K200422 · NFJ

Visionquest Biomedical, Inc.

Ophthalmic · 308d