Cdrh 510 k database search

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August undefined, 2024

Web510(k) Premarket Notification (Traditional) for ECHELON LINEARTM Cutter 510(k) Summary I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, … WebDatabases. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a …

510(k) Devices Cleared in 2024 FDA - U.S. Food and Drug …

WebBioFire® Global Fever Special Pathogens Panel 510(k) Summary BioFire Defense, LLC IV. Device Description The BioFire® Global Fever Special Pathogens Panel is a multiplexed … WebA search query will produce information from the database in the following format: You can search the releasable 510(k) database by Panel, 510(k) number, Product code or … A 510(K) is a premarket submission made to FDA to demonstrate that the device to … Listings of CDRH Substantially Equivalent 510(k)s are normally available about the … sims 3 best stuff packs

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Web510(k) Summary K223609 RevCore™ Thrombectomy Catheter The following “510(k) Summary” of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. 1.0 Submitter Information [ 21 CFR 807.92(a) (1)] Submitter: Inari Medical, Inc. Address: 6001 Oak Canyon, Suite 100 Irvine, CA 92618 USA Web510(K) Summary-K220673 1/5 510(K) Summary - K220673 This 510(K) Summary information is being submitted in accordance with 21 CFR 807.92. I. SUBMITTER: Qingdao Bright Moon Biomedical Materials Co., Ltd. No. 788, Bright Moon Road, Huangdao District, Qingdao, Shandong,China Contact Person: Deng yunlong WebFemDx Medsystems, Inc. Traditional 510(k) FemDx FalloViewTM Page 1 of 5 510(k) Summary Date Prepared: March 15, 2024 Submitter: FemDx Medsystems, Inc. 2336 Walsh Avenue, Suite A . Santa Clara, CA 95051 . Contact Person: Xi Francis, CEO . Email: [email protected] . Trade/Device Name: FemDx FalloView TM. Common … sims 3 bgc fight animation

Premarket Approval (PMA) - Food and Drug Administration

BioFire Defense, LLC March 22, 2024 David Rabiger Associate …

WebMay 2, 2024 · In accordance with that principle, since 510(k) applications are the most frequently requested CDRH records, CDRH is posting 510(k) records released to the … WebThe Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in … rbc 111 grangeway aveWeb510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device … rbc113 battery

"WebThese sets were previously cleared under 510(k) premarket notification K932512 on Feb 22, 1994. The devices covered in this submission are substantially equivalent to the … " - Cdrh 510 k database search

Cdrh 510 k database search

Web510(k)s; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device Classification; FDA … WebThese sets were previously cleared under 510(k) premarket notification K932512 on Feb 22, 1994. The devices covered in this submission are substantially equivalent to the predicate devices, previously cleared under 510(k) premarket notification K130245 on March 1, 2013. The intended use and function of the proposed devices are equivalent to

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WebFDA > CDRH > Device Registra Database Search. words connected by and (e.g., electromechanical and infusion). To Search by Establishment, Registration Number or … Web28 rows · Apr 6, 2024 · CDRH Databases: a listing of databases for such topics as …

Web510(K) Summary-K220673 1/5 510(K) Summary - K220673 This 510(K) Summary information is being submitted in accordance with 21 CFR 807.92. I. SUBMITTER: … WebJan 5, 2024 · This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2024. January 2024 510(K) Clearances; February 2024 …

WebThe Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical … Web510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device …

WebFDA Home Page CDRH Home Page Search CDRH A-Z Index Contact CDRH 510(k) Registration Listing Adverse Events PMA Classification CLIA CFR Title 21 …

WebCDRH maintains searchable databases on its website containing 510(k) and PMA information. A 510(k) is a premarketing submission made to FDA to demonstrate that the … rbc110 specificationsWebJul 27, 2009 · FDA > CDRH > CFR Title 21 Database Search Sec. 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). … sims 3 big city worldWeb510(k) Premarket Notification (Traditional) for ECHELON LINEARTM Cutter 510(k) Summary I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 Contact: Alicia Butler Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Phone: 513-337-1633 Email: [email protected] Date Prepared: December 15, 2024 II. sims 3 birth modWeb510(K) Number. Decision Date. single size tendon spacer: MEDIST INTERNATIONAL k000019: 03/29/2000: cortek mini laparoscope: CORTEK ENDOSCOPY, INC. k000199: … rbc 1145 barton street east fax numberWebGalaxy System 510(k) Notification Page 1 of 4 510(k) Summary This summary of 510(k) for information regarding substantial equivalency is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 510(k) Number: K223144 Applicant Information: Date Prepared: Manufacturer: Contact Person: Mobile Number: Fax: Device ... sims 3 big brotherWebMar 20, 2024 · While the CDRH Portal features online progress tracking for 510 (k) submissions, the FDA also formally notifies you of your 510 (k) submission's status by … rbc114 batteryWebBioFire® Global Fever Special Pathogens Panel 510(k) Summary BioFire Defense, LLC IV. Device Description The BioFire® Global Fever Special Pathogens Panel is a multiplexed nucleic acid-based test designed to be used with BioFire ®®FilmArray Systems (BioFire FilmArray® 2.0 or BioFire® FilmArray® Torch). The BioFire Global Fever Special … sims 3 black cc hair male