13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMBU MARK IV BABY RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00531421·
NOBELREPLACE CC PMC RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
DIASUS
FDA 510(k)
FDA Class 2
·Radiology
MICROMANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PRIMEADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·June 7, 2012
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
DA+ C SERIES DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·April 13, 2011
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·May 15, 2008
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