12 results · 19ms · Sources: EU EUDAMED, US FDA

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Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

FDA 510(k)
FDA Class 1 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777464·LUMBAMED PLUS FLEX PAD WM SILVER IV

Pilon Plate, 4mm

FDA UDI
I.T.S. GmbH·09120047297971·Pilon Plate, 4mm, 4-Hole

KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER

FDA 510(k)
FDA Class 2 ·Cardiovascular

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

GYNECARE PROLIFT

FDA Adverse Event
Injury ·GYNECARE·Product code FTL·October 23, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

FDA Recall
Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025