19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TEFLON COATED GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227620·Mini Fcps, 3mm smooth jaws
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051945·.022 L6R DBT/NC 0T 5 OFF
PROTECTOR P20-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 5, 2019
ULTRASONIC NEBULIZER, MODEL NE-520
FDA 510(k)
FDA Class 2
·Anesthesiology
SKYLINE 55, MODEL VER 1
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PHASEAL OPTIMA PROTECTOR (P20-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 25, 2019
BD PHASEAL OPTIMA PROTECTOR (P20-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 23, 2019
BD PHASEAL¿ PROTECTOR P20-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 5, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
UNKNOWN DEPUY PRODIGY 13.5 STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 15, 2010
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 8, 2013
SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 16, 2020
PROTECTOR P20-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 8, 2019
SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 20, 2020
BD PHASEAL¿ OPTIMA PROTECTOR (P20-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 4, 2019
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