12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690111733·Modular Tibia Augment Bolt Size 4mm
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809844856·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE ...
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BACT/ALERT CSR
FDA 510(k)
FDA Class 1
·Microbiology
PORTEX® ULTRAPERC® SINGLE DILATOR TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·October 17, 2019
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·May 16, 2008
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·October 14, 2019
Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
FDA Recall
Terminated
·Medtronic MiniMed·Product code LZG·January 28, 2004
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