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Office of Medical Device and Radiological Health Operations

View detailed information about Office of Medical Device and Radiological Health Operations, including compliance records, people, and regulatory data.

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Office Profile

Comprehensive profile of Office of Medical Device and Radiological Health Operations, including its role, location, and regulatory activities.

People (3)
Lakisha N. Morton
FDA_ASSOCIATED_PERSON
Lillian C. Aveta
FDA_ASSOCIATED_PERSON
Karen N. Archdeacon
FDA_ASSOCIATED_PERSON
Records (20)
483 - Premier Laboratory, LLC

biologics • May 14, 2025

483
483 - Join Parachute 7 LLC

biologics • June 23, 2023

483
483 - APC Pharma Carlsbad

biologics • June 22, 2017

483
483 - GenIbet Biopharmaceuticals SA

drugs • January 31, 2023

483
483 - Axogen Corp

drugs • April 29, 2025

483
483 - Dynavax GmbH

drugs • February 3, 2023

483
483 - Join Parachute 2 LLC

biologics • February 27, 2025

483
483 - Baxalta US Incorporated

biologics • June 24, 2016

483
483 - Neurotech Pharmaceuticals, Inc.

drugs • July 26, 2024

483
483 - FinVector Oy

drugs • September 27, 2022

483
483 - Clongen Laboratories LLC

biologics • June 17, 2025

483
483 - Replimune, Inc.

biologics • April 24, 2025

483
483 - Kedrion S.p.A.

drugs • April 7, 2025

483
483 - Kamada - Production Plant

drugs • February 3, 2023

483
483 - AGC Biologics, Inc.

biologics • April 22, 2016

483
483 - B Positive National Blood Services

biologics • Unknown Date

483
483 - PLIVA Hrvatska d.o.o.

drugs • May 31, 2018

483
483 - ABO Holdings Inc

biologics • November 21, 2024

483
483 - Moon Surgical

device • March 14, 2025

483
483 - Prothya Biosolutions Belgium

biologics • March 16, 2018

483

Showing 1 to 20 of 20 records

Related Offices (5)
Office of Compliance Intervention and Consultation
OCIC
Acting Division Director
Bureau of Environmental Health
Division of Nonprescription Drug Products
Division of Reproductive and Urologic Products
Office Information

Name

Office of Medical Device and Radiological Health Operations

Abbreviation

OMDRHO

Country

USA

Postal Code

20993

State/Province

Maryland

City

Silver Spring

Address

10903 New Hampshire Avenue, Building 32

Office Website

Visit Website

ID: 27658190-735a-443e-9087-3534cfe74fd4

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@keypedia.com
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