17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA-LITE 200E LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
FDA 510(k)
FDA Class 1
·General Hospital
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
FDA 510(k)
FDA Class 2
·Hematology
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·March 27, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·March 18, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC REDWOOD CITY·Product code MGB·March 31, 2008
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018