28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INCORIS TZI
FDA 510(k)
FDA Class 2
·Dental
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606630·SPACER 2123545 O25 23.5MM 18 DEG 16X45
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052454·3.5mm x 45mm Poly Screw Assm. The Atoll OCT Spi...
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014632698·SurgyCut Straight Blade with Suction & Electrod...
Sochi
FDA UDI
Altus Spine, LLC·00843210166568·Polyaxial Screw, 3.5mm x 45mm
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970577·
ULTRA-LITE 200E LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
BT-350
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 18, 2026
KANGAROO
FDA Adverse Event
Injury
·CARDINAL HEALTH 200, LLC·Product code KNT·April 6, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·April 17, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 1, 2026
FETAL MONITOR/CARDIOTOCOGRAM
FDA Adverse Event
Injury
·BISTOS CO., LTD.·Product code HGL·January 29, 2018
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 26, 2014
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·Product code LZG·October 2, 2015
ILIAC SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026