Search FDA 510(k) Database

Cleared May 31, 2022

Bone Cement-Normal Viscosity

K212729 · LOD

Biomecanica Industria E Comerciode...

Orthopedic · 277d

Cleared May 31, 2022

Distal Access Catheter

K213065 · QJP

Guangzhou Easycess Medical Co.,Ltd

Neurology · 250d

Cleared May 31, 2022

Fibrillar Collagen Wound Dressing

K213341 · KGN

Collagen Matrix, Inc.

General & Plastic Surgery · 236d

Cleared May 31, 2022

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows

K213731 · KPS

Ever Fortune.Ai, Co., Ltd.

Radiology · 186d

Cleared May 31, 2022

Respire Clear

K214096 · LRK

Respire Medical, LLC

Dental · 154d

Cleared May 31, 2022

Upper Arm Electronic Blood Pressure Monitor(Model...

K220113 · DXN

Shenzhen Finicare Co., Ltd.

Cardiovascular · 137d

Cleared May 31, 2022

eMurmur Heart AI

K220766 · DQD

Csd Labs GmbH

Cardiovascular · 76d

Cleared May 31, 2022

Rapid LVO

K221248 · QAS

Ischemaview, Inc.

Radiology · 29d

Cleared May 31, 2022

EchoNavigator R4.0

K221270 · LLZ

Philips Medical Systems Nederland B.V.

Radiology · 29d

Cleared May 31, 2022

Liverty™ TIPS Access Set

K221440 · DYB

Bard Peripheral Vascular, Inc.

Cardiovascular · 14d

Cleared May 28, 2022

Blue Nitrile Examination Gloves Powder Free

K212584 · LZA

Amazing Rubber Products Pvt, Ltd.

General Hospital · 285d

Cleared May 28, 2022

Amazing+ Latex Examination Powder Free Gloves

K212597 · LYY

Amazing Rubber Products Pvt, Ltd.

General Hospital · 285d

Cleared May 28, 2022

Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors,...

K213141 · LZA

Shen Wei (Usa), Inc.

General Hospital · 243d

Cleared May 27, 2022

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

K212268 · DQX

FMD Co., Ltd.

Cardiovascular · 311d

Cleared May 27, 2022

Single Use Hemoclip

K212669 · PKL

Zhejiang Chuangxiang Medical...

Gastroenterology & Urology · 277d

Cleared May 27, 2022

Benchmark Intracranial Access System

K212838 · QJP

Penumbra, Inc.

Neurology · 262d

Cleared May 27, 2022

Aspire Cristalle

K212873 · MUE

Fujifilm Corporation

Radiology · 260d

Cleared May 27, 2022

CoLink PCR Plating System

K213698 · HRS

In2bones USA, LLC

Orthopedic · 185d

Cleared May 27, 2022

VisAR

K220146 · OLO

Novarad Corporation

Orthopedic · 128d

Cleared May 27, 2022

MoistureMeterD Compact, LymphScanner

K220557 · OBH

Delfin Technologies, Ltd.

Gastroenterology & Urology · 88d

Cleared May 27, 2022

Spine Guidance Software, Stryker Q Guidance System

K220593 · OLO

Stryker Leibinger GmbH & Co KG

Orthopedic · 87d

Cleared May 27, 2022

Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs...

K220609 · LZA

Encompass Industries Sdn. Bhd.

General Hospital · 86d

Cleared May 27, 2022

SOLO-L

K220610 · OVD

Aurora Spine, Inc.

Orthopedic · 85d

Cleared May 27, 2022

Senhance Surgical System

K220889 · NAY

Asensus Surgical, Inc.

General & Plastic Surgery · 60d