19 results · 34ms · Sources: EU EUDAMED, US FDA

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syngo.CT Myocardial Perfusion

FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131281593·NERA2, BTE 13 WL 100 CNB

BA-1507-13

FDA UDI
PATHEN MEDICAL LLC·00850005864516·Administration set W/Spike, 150 Micron filter w...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100202·NEVYAS DRAPE SPECULUM OPEN WIRE

Bonding Accessories

FDA UDI
TP ORTHODONTICS INC·00192029000243·ADHESIVE, BRACKET-Tooth Conditioner, Resin

WATERPAP VALVE

FDA 510(k)
FDA Class 2 ·Anesthesiology

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511

FDA 510(k)
FDA Class 2 ·Immunology

VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code LJT·January 7, 2016

STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·July 10, 2025

MISAGO RX Self Expanding Peripheral Stem

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 7, 2016

STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 22, 2025

NAV STRAIGHT CUP POSITIONER

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·June 6, 2013

G2 FILTER SYSTEM - FILTER

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·June 24, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

FDA Adverse Event
Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

FDA Adverse Event
Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

VITAL-PORT

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code LJT·May 24, 2016

CLAMPING FOOT FOR 328.040 LCP 3.5MM AND LC-DCP 3.5MM

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·March 17, 2020