15 results
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6ms
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Sources: EU EUDAMED, US FDA
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 860010-1L
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
GreenLight HPSEA Laser Fibers, UPN 0010-2092
FDA Enforcement
Class III
·Ongoing·Boston Scientific Corporation·July 27, 2022
Penner Pacific Bathing Spa, Model Numbers 360020-1P
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
FDA Enforcement
Class III
·Ongoing·Olympus Corporation of the Americas·May 31, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
FDA Enforcement
Class III
·Ongoing·Olympus Corporation of the Americas·May 31, 2023
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344
FDA Enforcement
Class III
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 10, 2024
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
FDA Enforcement
Class III
·Ongoing·Sentinel CH SpA·July 14, 2021
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026