10 results
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19ms
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Sources: EU EUDAMED, US FDA
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
FDA 510(k)
FDA Class 1
·Microbiology
BIOCLONE
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750007431·Anti-A BIOCLONE 3x10ml
Stern EX Acid Etched Implant NP 3.3x15.0mm, Machined Collar, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109584·The Sterngold Acid Etch Dental Implant System c...
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300
FDA 510(k)
FDA Class 2
·Radiology
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
FDA 510(k)
FDA Class 2
·Immunology
SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014
TRI-LOCK BPS SZ 11 HI OFFSET
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·January 8, 2013
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 12, 2010
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