9 results
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27ms
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Sources: EU EUDAMED, US FDA
COULTER UREA NITROGEN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227750·House Mini Ear Fcps, very fine, .6x1mmcups, ang le
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111630·3M™ Victory Series™ First Molar Bands, 902-175,...
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
FDA 510(k)
FDA Class 1
·General Hospital
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
FDA 510(k)
FDA Class 2
·Cardiovascular
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·January 8, 2013
PFC SIGMA/OV/DOME PAT 3PEG,38
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code JWH·November 15, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014
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