17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFRARED EAR THERMOMETER, MODEL DX-707
FDA 510(k)
FDA Class 2
·General Hospital
US SENSOR #CG-930P; TOCO SENSOR CG-940P
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·September 5, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 27, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 18, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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