9 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoMed
FDA UDI
OSTEOMED LLC·00845694034890·3.5mm x 18mm Screw
RAPIDD HIGHSPEED DENTAL HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 11, 2013
DURASTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 17, 2011
PINNACLE 300 ACET CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 27, 2008
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 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