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

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DOLPHIN IMAGING

FDA 510(k)
FDA Class 2 ·Radiology

VaPro Plus Pocket

FDA UDI
HOLLISTER INCORPORATED·00610075053995·No Touch Urethral Intermittent Catheter with In...

Henschke Titanium Applicator

FDA UDI
Nucletron B.V.·08717213029910·Cervical Stopper

TRUELOK SYSTEM

FDA UDI
ORTHOFIX SRL·18033509856693·TL+ CANNULATED INLINE HINGE ASSEMBLY

Restore

FDA UDI
KEYSTONE DENTAL, INC.·D768L11043010K0·Drill

Restore

FDA UDI
KEYSTONE DENTAL, INC.·D768L11043015K0·Drill

Tecno

FDA UDI
TECNO INSTRUMENTS (PVT) LTD·08964001335474·Scoville-Greenwood 7.5” (19.1 cm), Insulated, T...

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012

URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

FDA 510(k)
FDA Unclassified ·Unknown

MLS-AC DERMA SCANNER

FDA 510(k)
FDA Class 2 ·Physical Medicine

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·March 22, 2024

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·May 7, 2024

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·February 9, 2026

TPRLC 133 MP TYPE1 BM SO 9.0

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 27, 2018

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 23, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 8, 2025

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40

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

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012