13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CPS DIRECT SL OUTER CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ASTRALIS 7, MODEL 557545
FDA 510(k)
FDA Class 2
·Dental
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 5, 2025
RAD-57 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-REDWOOD CITY·Product code MGB·May 28, 2008
ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0°, RETRO
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·November 21, 2018
ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWT·November 21, 2018
ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-0
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 2018
ANATOMICAL SHOULDER FRACTURE, HUMERAL STEM, 7-130
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 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