15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
WAKO AUTOKIT LP(A)/DADE DEMENSION
FDA 510(k)
FDA Class 2
·Immunology
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
3.5MM LCP PLATE 12 HOLES 163MM
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·September 11, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·April 5, 2011
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·January 16, 2014
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·June 10, 2013
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 22, 2011
G7 SCREW 6.5MM X 25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2019
INDUCTIGRAFT
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·February 16, 2012
HOSP SS FLEXX METER W/O LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Death
·LIFESCAN INC.·Product code NBW·April 1, 2011
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
FDA Enforcement
Class II
·Terminated·Solta Medical Inc·April 15, 2020
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