12 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BACTIDROP(TM) VOGES-PROSKAUER A
FDA 510(k)
FDA Class 1
·Microbiology
10PW - Heba Fire & Safety
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130033·10PW - Heba Fire & Safety
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869130030·osteotome caps, gas or steam permeable, latex-f...
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052015084·Analog Footswitch C2
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
FDA 510(k)
FDA Class 2
·Dental
CROSS-OVER HOODED LINER, 36MM ID
FDA Adverse Event
Malfunction
·STELKAST, INC.·Product code LWJ·January 14, 2013
SMALLBORE QUADFUSE W/.2 MICRON FILTER IV SET
FDA Adverse Event
Malfunction
·ICU MEDICAL INC.·Product code FPA·November 18, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024