14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLATELIA ASPERGILLUS EIA MODEL 62793
FDA 510(k)
FDA Class 1
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707065852·EXTRAORAL ELASTICS 1/2" 8 oz
VICTORCH MEDITEK'S HCG TEST CARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMISIL SCAR GEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/125MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NKB·March 12, 2013
CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·May 1, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 16, 2014
UNKNOWN DEPUY DIAPHYSIS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDS·May 12, 2011
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·October 6, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·July 15, 2025
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code ELC·September 9, 2016
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