11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
FDA 510(k)
FDA Class 2
·Radiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450641118·
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
FDA 510(k)
FDA Class 2
·Dental
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 6, 2013
TRIATHLON CR FEM COMP #2 L-CEM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·September 16, 2014
LIGHTSPEED VCT
FDA Adverse Event
Other
·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018