14 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GE SIGNA MR ONCOLOGY PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
PMMA disc
FDA UDI
Dentsply International Inc.·D00180819160·
Rutner
FDA UDI
COOK INCORPORATED·00827002149205·Rutner Suprapubic Balloon Catheter Set
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 26, 2021
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 29, 2024
ULTRA-FIT PK SYSTEM
FDA Adverse Event
Malfunction
·NETWORK MEDICAL·Product code HRH·August 27, 2009
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 11, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·April 5, 2011
ULTRA-FIT PK SYSTEM
FDA Adverse Event
Malfunction
·NETWORK MEDICAL PRODUCTS LTD.·Product code FRO·August 26, 2009
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 VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024