18 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NUVASIVE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033546·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...
MAXIM ACCEL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
FDA 510(k)
FDA Class 2
·Orthopedic
PERFORMANCE TOTAL KNEE PROSTHESIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019
PERFORMANCE DISTAL FAB LM/RL MED
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
PERFORMANCE DISTAL FAB LL/RM MED
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016
VANGRD CR POR/HA FEM - RT 72.5
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 31, 2016
TINBN VNGRD INT CR ANAT FEMORAL R 62.5 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 31, 2016
VANGUARD CR POROUS/HA FEM - RT 72.5
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 23, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
DISPOSABLE HIP STRAI
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY·Product code HAB·March 30, 2011
UNK DY
FDA Adverse Event
TYCO HEALTHCARE/KENDALL·Product code MPB·April 23, 2008
PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013
VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 20, 2017
VANGUARD CRUCIATE RETAINING POROUS HA FEMUR - RIGHT 65 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·May 12, 2017
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024