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

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STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL

FDA 510(k)
FDA Class 2 ·Anesthesiology

Rounded Flexi Tip Adult Enema Tip

FDA UDI
Bracco Diagnostics Inc.·10815112020993·Rounded Flexi Tip

Rounded Flexi Tip Adult Enema Tip

FDA UDI
Bracco Diagnostics Inc.·10815112021167·Rounded Flexi Tip

Surgimedics®

FDA UDI
COASTAL LIFE TECHNOLOGIES, INC.·00814716020104·Smoke Evacuation Filter

Tasso+

FDA UDI
Tasso Inc.·00850038691004·

METZENBAUM PREPARATION SCISSORS INSERT

FDA UDI
SONTEC INSTRUMENTS, INC.·B09929013010·METZENBAUM PREPARATION SCISSORS STRAIGHT DOUBLE...

3M™ Victory Series™

FDA UDI
3M UNITEK CORPORATION·00652221111357·3M™ Victory Series™ First Molar Bands Kit, Lowe...

ORTHOPANTOMOGRAPH™ OP 3D

FDA UDI
PaloDEx Group Oy·06430035875177·ORTHOPANTOMOGRAPH™ OP 3D EX (PAN 3D)

Miracle Suction FULL Kit

FDA UDI
DiaDent Group International·08806383524445·Multifunctional Mirror with Suction

EYEVAN7285

FDA UDI
EYEVAN INC.·04571445021098·

ShurFit MALIF System

FDA UDI
PRECISION SPINE, INC.·00840019925228·Cup Curette 4mm Straight Up Cup

STALIF MIDLINE

FDA 510(k)
FDA Class 2 ·Orthopedic

LIFE SPINE STAND-ALONE SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 30, 2019

FORTIFY VR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 8, 2013

PALMAZ GENESIS ON AMIIA

FDA Adverse Event
Injury ·CORDIS EUROPA, N.V.·Product code FGE·November 17, 2010

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40

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

SmartPath to dStream for 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021