12 results · 37ms · Sources: EU EUDAMED, US FDA

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VitalDetect

FDA 510(k)
FDA Class 2 ·General Hospital

BD BBL™ Sensi-Disc™ Azlocillin - 75 µg

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316252·BD BBL™ Sensi-Disc™ Azlocillin - 75 µg

Meridian

FDA UDI
Seaspine Orthopedics Corporation·10889981247331·No-Profile Interbody, 39mm x 30mm x 16mm, 25 Deg

POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED

FDA 510(k)
FDA Class 1 ·General Hospital

ANYSCAN-S SPECT IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·November 13, 2008

6 SHOOTER SAEED MULTI-BAND LIGATOR

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC.·Product code MND·August 15, 2011

UNKNOWN SOFRADIM PRODUCT

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·July 12, 2013

KIDS OXYGENATOR D101

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025

VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CGA·September 27, 2006

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022