14 results · 22ms · Sources: EU EUDAMED, 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