15 results · 28ms · Sources: EU EUDAMED, US FDA

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EMPRESS DIRECT

FDA 510(k)
FDA Class 2 ·Dental

Young

FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302730907018·Young Prophy Brush, Soft, Long Flat White Nylon...

LEONE SPA

FDA UDI
LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green

LOCATOR R-Tx

FDA UDI
Zest Anchors, LLC·00840481120794·Attachment System, WP, Tissue Level, Blue Sky B...

Orthopedic manual surgical instrument

FDA UDI
BAUI BIOTECH CO. LTD.·04718005151899·Gun-type Pull-up Pliers

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 30, 2019

Phonak

FDA UDI
Phonak AG·07612847809284·Phonak Ambra SP (beige)

HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER

FDA 510(k)
FDA Class 2 ·Immunology

MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Dental

0.8% RESOLVE PANEL B FOR GEL

FDA Adverse Event
Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·May 2, 2013

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 15, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

FDA Enforcement
Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018