Cdrh 510 k database search
WebSearch the Releasable 510(k) Database; 510(k) Devices Cleared in 2024; 510(k) Devices Cleared in 2024; 510(k) Devices Cleared in 2024; 510(k) Devices Cleared in 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 …
Cdrh 510 k database search
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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 … Web510(k) Premarket Notification (Traditional) for ECHELON LINEARTM Cutter 510(k) Summary I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, …
Web510(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. WebThe Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in …
Web510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device … 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 …
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
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 … haviland china collectorsbosch apprenticeship program usaWebMar 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 … haviland china cloverWebA 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 … haviland cemeteryWebThese 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 … bosch april dishwasher couponWeb510(K) Number. Decision Date. single size tendon spacer: MEDIST INTERNATIONAL k000019: 03/29/2000: cortek mini laparoscope: CORTEK ENDOSCOPY, INC. k000199: … boscha presseckWebBioFire® Global Fever Special Pathogens Panel 510(k) Summary BioFire Defense, LLC IV. Device Description The BioFire® Global Fever Special Pathogens Panel is a multiplexed … bosch aps2