10 results
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20ms
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Sources: EU EUDAMED, US FDA
COULTER SERUM IRON/UIBC REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111616·3M™ Victory Series™ First Molar Bands, 902-173,...
Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·May 12, 2020
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LZO·May 7, 2014
PFC SIGMARP CV TB/IN S5 10.0
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·November 15, 2010
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 8, 2013
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
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013