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

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OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Pads

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968936·Pad 215x100 G

Hillrom™

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975996·Trumpf Medical/Medizin Pad 215x100 G

WOUND PROTECTOR/RETRACTOR

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

PHILIPS BV PULSERA/ENDURA

FDA 510(k)
FDA Class 2 ·Radiology

HAHN TAPERED IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 5, 2025

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

AJUST ADJUSTABLE SINGLE INCISION SLING

FDA Adverse Event
Injury ·BARD SHANNON LTD·Product code FTL·April 24, 2013

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·April 22, 2011

NXSTAGE SYTEM ONE

FDA Adverse Event
Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·July 21, 2008

HAHN TAPERED IMPLANT 4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 26, 2022

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014