Search FDA 510(k) Database

Cleared Mar 29, 2019

Thoracic VCAR with GSI Pulmonary Perfusion

K183210 · LLZ

GE Medical Systems SCS

Radiology · 130d

Cleared Mar 29, 2019

Micro Transgastric-Jejunal Feeding Device

K183508 · KNT

Applied Medical Technology, Inc.

Gastroenterology & Urology · 101d

Cleared Mar 29, 2019

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu...

K183579 · GZF

Boston Scientific Neuromodulation

Neurology · 98d

Cleared Mar 29, 2019

Klassic Knee System - Klassic Knee PS-Post Femur

K183596 · JWH

Total Joint Orthopedics, Inc.

Orthopedic · 98d

Cleared Mar 29, 2019

BTL-084

K190023 · PBX

BTL Industries, Inc.

General & Plastic Surgery · 84d

Cleared Mar 29, 2019

Monaco RTP System

K190178 · MUJ

Elekta, Inc.

Radiology · 56d

Cleared Mar 29, 2019

Pusen Eview Medical Video Endoscope Image Processor

K190648 · FET

Zhuhai Pusen Medical Technology Co.,...

Gastroenterology & Urology · 16d

Cleared Mar 28, 2019

V.A.C. DERMATAC Drape

K181505 · OMP

Kci USA, Inc.

General & Plastic Surgery · 294d

Cleared Mar 28, 2019

FUJIFILM Duodenoscope Model

K181745 · FDT

Fujifilm Corporation

Gastroenterology & Urology · 269d

Cleared Mar 28, 2019

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use...

K182176 · KGO

Pt. Medisafe Technologies

General Hospital · 230d

Cleared Mar 28, 2019

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic...

K190186 · IYO

Edan Instruments, Inc.

Radiology · 55d

Cleared Mar 28, 2019

AirSeal

K190303 · HIF

Conmed Corporation

General & Plastic Surgery · 44d

Cleared Mar 27, 2019

Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set

K181735 · LJE

Cook Incorporated

Gastroenterology & Urology · 268d

Cleared Mar 27, 2019

eKuore One electronic interface for stethoscope

K181882 · DQD

Chip Ideas Electronics S.L.

Cardiovascular · 257d

Cleared Mar 27, 2019

MiMo(TM) Negative Pressure Wound Therapy System

K181929 · OMP

Baymax Research, Inc.

General & Plastic Surgery · 252d

Cleared Mar 27, 2019

Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and...

K182738 · DKZ

Hangzhou AllTest Biotech Co., Ltd.

Toxicology · 180d

Cleared Mar 27, 2019

Accutorr 7/VS-900/VS-900c Vital Signs Monitor

K182821 · MWI

Shenzhen Mindray Bio-Medical...

Cardiovascular · 174d

Cleared Mar 27, 2019

WOLF Thrombectomy Device

K182835 · QEW

880 Medical, LLC

Cardiovascular · 169d

Cleared Mar 27, 2019

Mimics Medical

K183105 · LLZ

Materialise NV

Radiology · 139d

Cleared Mar 27, 2019

AMSCO 600 Steam Sterilizer

K183410 · FLE

STERIS Corporation

General Hospital · 107d

Cleared Mar 27, 2019

Wearable Device, Home Package in Carry Case with Homehub, Home Package in...

K190073 · MSX

Current Health , Ltd.

Cardiovascular · 70d

Cleared Mar 27, 2019

Tyto Thermometer

K190242 · FLL

Tyto Care , Ltd.

General Hospital · 49d

Cleared Mar 27, 2019

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...

K190302 · OZE

Centers For Disease Control and...

Microbiology · 43d

Cleared Mar 27, 2019

Responsive Arthroscopy Wedge Push-In Suture Anchors

K190446 · MBI

Responsive Arthroscopy, LLC

Orthopedic · 30d