24 results · 22ms · Sources: EU EUDAMED, US FDA

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SILK, NONABSORBABLE, SURGICAL SUTURES, USP

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

Leksell Stereotactic System

FDA UDI
Elekta Instrument AB·07340048305266·ARC ATTACHMENT FOR COUNTER SCALE

Coagulation RF cable

FDA UDI
ATRICURE, INC.·10840143901485·

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001184·artVeneer life upper anteriors, ITS, B1

Diagon

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO0011840·15°, 12mm x 39mm x 16mm Oblique ASM

AUDIOSCREENER OAE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

TRANS FX ADJUSTABLE PIN TO BAR CLAMP

FDA 510(k)
FDA Class 2 ·Orthopedic

CS100

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 21, 2023

HERO GRAFT

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code DSY·August 3, 2015

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·February 11, 2025

HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·March 8, 2013

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code MCX·February 24, 2011

CONTOUR TEST STRIPS (50)

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·February 26, 2024

HERO GRAFT

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code DSY·July 31, 2015

HERO GRAFT

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code DSY·August 3, 2015

HERO GRAFT

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code DSY·June 15, 2015

HERO GRAFT

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code DSY·June 15, 2015

HERO GRAFT

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code DSY·June 9, 2015

Xhibit Telemetry Receiver, Model: 96280

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022