15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071563·STRIPE GAME FENICE, SIZE S, NERO, GRADUATED COM...
Sklar
FDA UDI
SKLAR CORPORATION·30649111147214·RUBBER JAWS FOR YOUNG FCP PK/2
NA
FDA UDI
STERILMED, INC.·10888551007658·SAW BLADE OSCILLATING LARGE BONE
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRASSELER SAW BLADE
FDA Adverse Event
Injury
·BRASSELER USA·Product code GFA·October 21, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
ISE INDIRECT NA+ FOR GEN.2
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·April 28, 2011
R-I-FLOW PAIN BUSTER
FDA Adverse Event
Injury
·R-I-FLOW CORPORATION·Product code MEB·July 9, 2008
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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022