21 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVEREST SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
M-Flex®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020180·Blue Silicone Tungsten Maloney Esophageal Dilat...
Logical 20° Hooded Liner
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215009441·
Logical Cup Liner
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215054182·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111206560·Liner, 36-56/58mm (20° Hood)
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)
FDA 510(k)
FDA Class 2
·Physical Medicine
VENTO XLPE Liner
FDA UDI
AMPLITUDE SAS·03701089514613·
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 17, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 15, 2024
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015