19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PLASTIC DISPOSABLE RAZOR CAT.#1017,1018
FDA 510(k)Sphero Attachment
FDA UDI
Preat Corporation·00842092115046·Sphero Block Abutment Astra 3.0 x 3mm (1.8mm Ball)
Two Striper
FDA UDI
ABRASIVE TECHNOLOGY, INC.·B868C8020031·Dental Root Canal Post
Zavation
FDA UDI
Zavation LLC·00842166174887·Lock Screw
Dermatome
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024375956·Dermatome 3" Width Plate
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
FDA 510(k)
FDA Class 2
·Radiology
XPRESS BALLOON DEVICE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·August 19, 2013
BD¿ SYRINGE PLASTIPAK LUER SLIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 26, 2018
HANDPIECE, ELECTRIC DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·April 21, 2026
ZIMMER AIR DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·November 3, 2025
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·June 28, 2013
HANDPIECE, ELECTRIC DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·April 1, 2026
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 23, 2012
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·May 28, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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