16 results · 29ms · Sources: EU EUDAMED, US FDA

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Uroflowmeter

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1424250·14mm H x 24mm W x 25mm L x 0 degrees XLIF

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704508529·SCISSORS ESMARCH BANDAGE 7.5"

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L142425120·14mm H x 24mm W x 25mm L XLIF Trial 12 degree L...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X142425120·14mm H x 24mm W x 25mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X14242580·14mm H x 24mm W x 25mm L x 8 degrees XLIF

ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 14, 2024

STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·October 2, 2025

GYNECARE MORCELLEX* TISSUE MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·June 3, 2013

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 28, 2011

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 5, 2014

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024