14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CVS PERSONAL LUBRICANT AND MOISTURIZER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REPROCESSED LASER PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 17, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 18, 2008
BLUNT TIP SCREW, 4X38MM
FDA Adverse Event
Malfunction
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·June 25, 2021
BLUNT TIP SCREW, 4X38MM
FDA Adverse Event
Malfunction
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·June 23, 2021
PROXIMAL HUMERUS, LEFT, 9X160MM
FDA Adverse Event
Malfunction
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·June 23, 2021
BLUNT TIP SCREW, 4X40MM
FDA Adverse Event
Malfunction
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·June 23, 2021
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Malfunction
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·June 23, 2021
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