11 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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ARTHROCARE PERCD SPINEWAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Graves Vu-More Large
FDA UDI
MEDGYN PRODUCTS, INC.·M803030954·Graves Vu-More Large 5" (127mm)
KERR GEL ETCHANT
FDA 510(k)
FDA Class 2
·Dental
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
FDA 510(k)
FDA Class 2
·Orthopedic
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGZ·April 2, 2013
LIGASURE IMPACT
FDA Adverse Event
Injury
·VALLEYLAB·Product code GEI·March 15, 2011
INDURA
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LKK·April 17, 2008
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 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