19 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL MEDICAL DEVICE CAUTERY
FDA 510(k)
FDA Class 2
·Ophthalmic
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154184508·Locking Screws, Cross-Pin
YELLOW SPECIAL
FDA 510(k)
FDA Class 2
·Dental
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
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
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 28, 2025
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
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 27, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP·Product code CBK·April 2, 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
Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG and standard SPO2 option.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
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