1,025 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 5/8"X50YDS Catalog # GL-241. e. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE WHT W/O APPL 11/2"X50YDS Catalog # GL-243
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Heraeus, PALAMIX duo. Material Number: 66057897.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Heraeus, PALAMIX uno. Material Number: 66057893.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Philips OMNI II TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 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
Philips OMNI III TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips X7-2 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Philips S4-1 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 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 350010-1, 350000-2, 350010-X
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Philips C9-4 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips L17-5 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips Mini Multi TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
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
Philips 3D6-2 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Penner Pacific Bathing Spa, Model Numbers 360020-1P
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