Search FDA 510(k) Database

Cleared Oct 11, 2019

K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2”...

K192057 · FMI

Terumo Europe N.V.

General Hospital · 71d

Cleared Oct 11, 2019

CarboClear VBR System

K192214 · MQP

CarboFix Orthopedics , Ltd.

Orthopedic · 57d

Cleared Oct 11, 2019

AEON Laparoscopic Instruments

K192235 · GEI

Lexington Medical, Inc.

General & Plastic Surgery · 53d

Cleared Oct 11, 2019

Zimmer Natural Nail System Cephalomedullary Nails

K192312 · HSB

Zimmer GmbH

Orthopedic · 46d

Cleared Oct 11, 2019

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20,...

K192515 · LDJ

Shenzhen Bioeasy Biotechnology Co., Ltd.

Toxicology · 28d

Cleared Oct 10, 2019

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

K182136 · NUH

Shenzhen Osto Technology Co., Ltd.

Neurology · 430d

Cleared Oct 10, 2019

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization...

K182184 · FRG

Mdk (Shanghai) Medical Packing Co., Ltd.

General Hospital · 423d

Cleared Oct 10, 2019

Waterlase Laser System Family

K190319 · GEX

Biolase, Inc.

General & Plastic Surgery · 239d

Cleared Oct 10, 2019

KTA Adipose Treatment Kit

K190386 · MUU

Stemics S.A.S

General & Plastic Surgery · 233d

Cleared Oct 10, 2019

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory –...

K190523 · PJN

Ossdsign AB

Neurology · 220d

Cleared Oct 10, 2019

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR

K190772 · IZI

Olympus Medical Systems Corp.

Neurology · 198d

Cleared Oct 10, 2019

Palladium High Flow Therapy System

K191010 · BTT

Vapotherm, Inc.

Anesthesiology · 177d

Cleared Oct 10, 2019

Mercy babyTAPE

K191174 · PIR

Children'S Mercy Hospital

General Hospital · 162d

Cleared Oct 10, 2019

Belun Ring

K191417 · DQA

Belun Technology Company Limited

Anesthesiology · 135d

Cleared Oct 10, 2019

Legacy SMARTBase Abutments

K191458 · NHA

Implant Direct Sybron Manufacturing, LLC

Dental · 132d

Cleared Oct 10, 2019

Instylla Delivery Kit

K191659 · FMF

Instylla, Inc.

General Hospital · 111d

Cleared Oct 10, 2019

SMR Finned Short Stems

K191963 · MBF

Lima Corporate S.P.A.

Orthopedic · 79d

Cleared Oct 10, 2019

Halyard ONE-STEP* Sterilization Wrap

K192147 · FRG

Owens & Minor (O&M) Halyard, Inc.

General Hospital · 63d

Cleared Oct 10, 2019

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

K192210 · FLL

Fiab Spa

General Hospital · 57d

Cleared Oct 10, 2019

DigiFix Sterile Kit

K192465 · JEC

Virak Orthopedics, LLC

Orthopedic · 31d

Cleared Oct 10, 2019

VERA

K192474 · LXJ

Reflexion Health, Inc.

Physical Medicine · 30d

Cleared Oct 10, 2019

Spine Wave Navigated Instruments

K192526 · OLO

Spine Wave, Inc.

Orthopedic · 27d

Cleared Oct 09, 2019

AnyRidge Octa 1 Implant System

K182448 · DZE

Megagen Implant Co., Ltd.

Dental · 397d

Cleared Oct 09, 2019

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

K190314 · IYO

Mednovel Technology, Ltd.

Radiology · 238d