15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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