16 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPSURE PS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NexxZr™ T / D-100-35-NT-D200-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113641·
Reef TO
FDA UDI
Seaspine Orthopedics Corporation·10889981190620·Interbody, 11mm x 32mm x 15mm, 5 Deg
Reef TO
FDA UDI
Seaspine Orthopedics Corporation·10889981204778·Trial, 11mm x 32mm x 15mm, 5 Deg
WaveForm TO
FDA UDI
Seaspine Orthopedics Corporation·10889981288914·Interbody, 11mm x 32mm x 15mm, 5 Deg, 3D
G-FREEZEKIT BLAST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·July 13, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 7, 2016
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 1, 2014
SQUARE CHAIR SENSOR PAD
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·May 1, 2013
DUROM US ACETABULAR COMPONENT 58/52 R
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 1, 2011
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·August 15, 2012
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
FDA Enforcement
Class II
·Terminated·Amendia, Inc·December 28, 2016
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023