17 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
FDA 510(k)
FDA Class 2
·Anesthesiology
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
FDA 510(k)
FDA Class 2
·Radiology
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 7, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·June 18, 2008
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 12, 2011
AVAN TAP CORT SCR SS 4.5X26MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X56MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X20MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X52MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
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