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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SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endo-Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964014701·Endo Carry-on Procedur Kit contains all of the ...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040054649·Strip Crown Forms
PIC Plus
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783000177·PIC Plus Value Pack - Pink
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001555·artVeneer life lower anteriors, UBIL, BL1
Scanlan® VASCU-STATT® Plus single-use bulldog clamp w/Gentle-Jaw™ surface
FDA UDI
SCANLAN INTERNATIONAL INC·00846159000658·Scanlan® VASCU-STATT® Plus single-use bulldog c...
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
FDA 510(k)
FDA Class 1
·General Hospital
MODEL 4300 PSARRAY EEG ELECTRODE SET
FDA 510(k)
FDA Class 2
·Neurology
INFINION? PRO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 29, 2025
SEXTANT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009
FLEX2
FDA Adverse Event
KING SYSTEMS CORPORATION·Product code CAI·February 10, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·January 26, 2011
RESTORE RECHARGER
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·February 21, 2008
SENHANCE
FDA Adverse Event
Injury
·ASENSUS SURGICAL, INC.·Product code NAY·September 19, 2023
A3213, CLAMP (SIZE 5-30)
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code DXC·June 27, 2024
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013