17 results · 20ms · Sources: EU EUDAMED, US FDA

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COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20415401·Arch wires Titanol Superelastic Straight-Arch-F...

JEDMED

FDA UDI
JEDMED INSTRUMENT COMPANY·M6330415400·"S-II" Chair Manual Base

VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07

FDA 510(k)
FDA Class 2 ·Cardiovascular

RUSCH EDGAR TUBE

FDA 510(k)
FDA Class 2 ·Anesthesiology

LIFESHIELD LATEX FREE SYMBIQ PUMP SET

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2012

UNK

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

UNK

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 1, 2010

UNK

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·January 7, 2011

3.5MM 90-S SERFAS ENERGY SUCTION PROBE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·April 8, 2013

NEW LIGASURE 5MM

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·March 10, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 10, 2025

THERAPY ABLATION CATHETER

FDA Adverse Event
Malfunction ·IRVINE BIOMEDICAL, INC.·Product code LPB·October 17, 2008

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024