15 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CATALYSY
FDA 510(k)
FDA Class 1
·Physical Medicine
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496062660·CURVY 140 OPAQUE, SIZE L-XL, MOKA, GRADUATED CO...
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015
HARDYDISK LOMEFLOXACIN, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·April 17, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·June 11, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 11, 2011
Z NAIL CMF 10.5 X 110 LAG SCR
FDA Adverse Event
Malfunction
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·November 11, 2021
Z NAIL CMF 11.5MMX21.5CM 130 R
FDA Adverse Event
Malfunction
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·November 11, 2021
2.7MM TI METAPHYSEAL SCREW SLF-TPNG/T8 STRDRV/36MM-ST
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·March 21, 2016
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation.
FDA Enforcement
Class II
·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015