11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428648353·A hand-held battery-powered electronic instrume...
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PALMLIGHT
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2024
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code HXX·October 10, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
GOODBABY·Product code IOR·July 2, 2013
AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 7, 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