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IMAGEN RESPIRATORY SCREEN

FDA 510(k)
FDA Class 1 ·Microbiology

Reducing Solution

FDA registration
RICHARD-ALLAN SCIENTIFIC LLC·1 product·🇺🇸 United States

Shijiazhuang Wally Plastic Co., Ltd

Manufacturer
🇨🇳 China·3 Basic UDI-DIs·25 Devices

Anhui Bioer Technology Co., Ltd.

Manufacturer
🇨🇳 China·3 Basic UDI-DIs·4 Devices

Motion Medical Distributing

FDA UDI
Haslam Medical, Inc.·15060498451908·Cricothyrotomy Kit #1634 Contents: (1) ET Tube ...

Validate

FDA UDI
Lgc Clinical Diagnostics, Inc.·00859110005548·Validate Body Fluids is intended for the quanti...

Validate

FDA UDI
Lgc Clinical Diagnostics, Inc.·00859110005555·Validate Body Fluids is intended for the quanti...

Eversense 365 Continuous Glucose Monitoring (CGM) System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Eversense AP CGM System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Rontis Corporation SA

Manufacturer
🇨🇭 Switzerland·225 Basic UDI-DIs·443 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and TUV NORD Polska Sp. z o.o

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Talent Endoluminal Occl

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Harmony™ Delivery Catheter System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting

POWDER FREE LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

FDA 510(k)
FDA Class 1 ·General Hospital