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iRhythm Technologies Inc. Cypress, CA. 483 issued 07/31/2024

Task Description Request Please post to the ORA Electronic Reading Room Record Date 07/31/2024 Short Title (70 char) iRhythm Technologies Inc. Cypress, CA. 483 issued 07/31/2024 FEI Number 3021769057

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29 Aug 2024

Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli

ClotTriever XL is used to remove clots and blockages in large vessels. Inari is updating Use Instructions after reports of entrapment and pulmonary emboli.

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29 Aug 2024

August 27, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA orangebook
29 Aug 2024

August 26, 2024

FDA expands indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and ol

FDA orangebook
29 Aug 2024

August 23, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA orangebook
29 Aug 2024

Do You Need a Device That Claims to Clean a CPAP Machine?

Most CPAP accessories such as hoses or tubes and masks can be cleaned with only mild soap and water. Follow your CPAP manufacturer's instructions.

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29 Aug 2024

Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail

Syringes included in Medline Convenience Kits should not be used due to risk for contamination, breakage, or leakage.

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23 Aug 2024

COVID-19 Vaccines for 2024-2025

The FDA has approved and authorized for emergency use updated COVID-19 vaccines (2024-2025 formula) that include a monovalent (single) component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2.

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23 Aug 2024

OTP Pre-BLA Meetings

OTP Pre-BLA meeting information

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23 Aug 2024

OTP IND End of Phase Meetings

OTP IND End of Phase Meetings Information

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23 Aug 2024

OTP Type A Meetings

Information about OTP Type A Meetings

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23 Aug 2024

OTP Meetings for Approved Products

Information about OTP Meetings for Approved Products

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23 Aug 2024

Interactions with Office of Therapeutic Products

Information regarding Interactions with Office of Therapeutic Products

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23 Aug 2024

Drug Trials Snapshots: PIASKY

Drug Trials Snapshots: PIASKY

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23 Aug 2024

FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

FDA approved and authorized for emergency use updated mRNA COVID-19 vaccines (2024-2025 formula) to more closely target currently circulating variants to prevent COVID-19 and to provide better protection against serious consequences of COVID-19.

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23 Aug 2024

Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions

The RMU-2000 ARM XR Chest Compression Device provides external chest compressions. A motor issue may cause the device to unexpectedly stop.

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23 Aug 2024

August 22, 2024

FDA approved and authorized for emergency use updated mRNA COVID-19 vaccines (2024-2025 formula) to more closely target currently circulating variants to prevent COVID-19 and to provide better protection against serious consequences of COVID-19.

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23 Aug 2024

Electronic Regulatory Submission and Review

This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.

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21 Aug 2024

Global IDMP Implementation - Getting Closer to the Goal - 10/16/2024

Global IDMP Implementation - Getting Closer to the Goal

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21 Aug 2024

FDA Roundup: August 20, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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21 Aug 2024

Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery

If a Plum 360, A+ or A+3 pump is running on battery power with no AC backup, an ongoing infusion may be stopped when batteries unexpectedly run out.

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21 Aug 2024

August 20, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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21 Aug 2024

Intercos Europe S.p.A - 682273 - 08/15/2024

CGMP/Finished Pharmaceuticals/Adulterated

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20 Aug 2024

Eugia Pharma Specialities Limited - 681905 - 08/15/2024

CGMP/Finished Pharmaceuticals/Adulterated

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20 Aug 2024
FDA orangebook
20 Aug 2024
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