Search FDA 510(k) Database

Cleared Sep 20, 2019

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

K192301 · NFW

Shenzhen Bioeasy Biotechnology Co., Ltd.

Toxicology · 28d

Cleared Sep 20, 2019

ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath

K192332 · QEW

Inari Medical

Cardiovascular · 24d

Cleared Sep 20, 2019

syngo.CT Extended Functionality

K192402 · JAK

Siemens Medical Solutions USA, Inc.

Radiology · 17d

Cleared Sep 19, 2019

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

K182631 · INI

Eurogreen International, Inc.

Physical Medicine · 360d

Cleared Sep 19, 2019

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

K190526 · PML

CarboFix Orthopedics , Ltd.

Orthopedic · 199d

Cleared Sep 19, 2019

GEHC DXA Bone Densitometers with enCORE version 18

K191112 · KGI

GE Medical Systems Ultrasound &...

Radiology · 146d

Cleared Sep 19, 2019

RS80 EVO Diagnostic Ultrasound System

K192030 · IYN

Samsung Medison Co., Ltd.

Radiology · 51d

Cleared Sep 19, 2019

ProPerformance Recovery System

K192252 · IRP

Menlo Brands, LLC

Physical Medicine · 30d

Cleared Sep 19, 2019

HardyDisk AST Lefamulin 20µg (LMU20)

K192326 · JTN

Hardy Diagnostics

Microbiology · 23d

Cleared Sep 19, 2019

Sapphire NC Plus Coronary Dilatation Catheter

K192344 · LOX

Orbusneich Medical Trading, Inc.

Cardiovascular · 21d

Cleared Sep 18, 2019

VORTRAN APM-Plus

K182292 · CAP

Vortran Medical Technology 1, Inc.

Anesthesiology · 391d

Cleared Sep 18, 2019

EMS Belt (Model MC0485)

K183103 · NGX

Dongguan Yingfeng Metal & Plastic...

Physical Medicine · 315d

Cleared Sep 18, 2019

OraCure

K183436 · OLR

Tbm Corporation

Dental · 281d

Cleared Sep 18, 2019

4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK...

K190563 · MAX

Solco Biomedical Co., Ltd.

Orthopedic · 197d

Cleared Sep 18, 2019

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA...

K190858 · NUC

United Consortium

Obstetrics & Gynecology · 169d

Cleared Sep 18, 2019

geko T-2 and geko T-3 Neuromuscular Stimulators

K191113 · IPF

Firstkind Limited

Physical Medicine · 145d

Cleared Sep 18, 2019

Dornier MINNOW Ureteral Catheter

K191187 · EYB

Dornier Medtech America, Inc.

Gastroenterology & Urology · 138d

Cleared Sep 18, 2019

AccuCath Ace Intravascular Catheter

K191232 · FOZ

C.R. Bard, Inc.

General Hospital · 133d

Cleared Sep 18, 2019

Flexible HD Cysto-Urethroscope System

K191357 · FAJ

KARL STORZ Endoscopy-America, Inc.

Gastroenterology & Urology · 120d

Cleared Sep 18, 2019

HEDRON Lumbar Spacers

K191391 · MAX

Globus Medical, Inc.

Orthopedic · 117d

Cleared Sep 18, 2019

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602...

K191457 · PFO

Med-El Elektromedizinische Geraete GmbH

Ear, Nose, Throat · 110d

Cleared Sep 18, 2019

GM501 Mineral Oil

K191552 · MQL

Hamilton Thorne, Inc.

Obstetrics & Gynecology · 98d

Cleared Sep 18, 2019

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

K191663 · IYN

Canon Medical Systems Corporation

Radiology · 89d

Cleared Sep 18, 2019

Syngo.Via RT Image Suite

K192065 · MUJ

Siemens Medical Solutions USA, Inc.

Radiology · 48d