1,025 results
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9ms
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Sources: EU EUDAMED, US FDA
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·April 2, 2014
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·December 4, 2013
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·May 8, 2019
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