10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Prase PEEK Anterior Cervical Interbody Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Synthes GmbH·10886982145055·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112571·BARRON CORNEAL PUNCH 6.5MM
GE ROAD WARRIOR PET CT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
R&D PROJECT DW271#11A
FDA 510(k)
FDA Class 2
·Dental
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 17, 2008
JUGGERKNOT SINGLE LOADED SZ. 1
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE, INC.·Product code MBI·August 11, 2011
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 2, 2013
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 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