15 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
FDA 510(k)
FDA Class 2
·Neurology
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013
SYNERGY HA COATED POROUS FEMORAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
BARBITURATES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DELTA CER FM HD 036/-4MM 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 23, 2026
UNKNOWN AVANTAGE HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 6, 2025
1.8MM TI LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWP·April 17, 2013
LINOX S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·April 11, 2011
PULSE GEN MODEL 102R
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 18, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 2, 2017
32MM COCR BIOMET FEM HD -3 NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·April 30, 2025
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
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