20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
6F MACH 1, MODEL 34356-XXX
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743618·LEVAMED ANKLE SUPPORT SAND IV
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR50108741·NiTi wire bending plier Hammerhead max. .025"
SCHEU-DENTAL GMBH
FDA registration
SCHEU-DENTAL GMBH·4 products·🇩🇪 Germany
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00887661445650·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033219256·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00887661445667·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00887661445674·
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 23, 2025
PERIPHERALLY INSERTED CENTRAL CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD SYRINGES WITH PRECISIONGLIDE NEEDLE & LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 1, 2018
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 14, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 3, 2011
CURRENT RF DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
PICC-NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004
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