21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vela RX PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293241·
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100806·FLIERINGA FIXATION RING 19MM
Venture Heat
FDA UDI
MATSUM INC·00876594009671·Infrared Heated Back Wrap (S/M)
Venture Heat
FDA UDI
MATSUM INC·00876594000043·Infrared Heated Back Wrap (XXL/XXXL)
Venture Heat
FDA UDI
MATSUM INC·00876594009688·Infrared Heated Back Wrap (L/XL)
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100676·K7-1290-47
Brasseler
FDA UDI
Provision·B504OMK71290500·
Brasseler
FDA UDI
Provision·B504OMK71290470·
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100683·K7-1290-50
NA
FDA UDI
STERILMED, INC.·10888551007498·SAW BLADE OSCILLATING AGGRESSIVE CUT LARGE BONE
NA
FDA UDI
STERILMED, INC.·10888551016131·SAW BLADE OSCILLATING AGGRESSIVE CUT LARGE BONE
PIEZO BONE SURGERY
FDA 510(k)
FDA Class 2
·Dental
AQUAMANTRYS3 BSC 9.1S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·June 14, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 21, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·Product code KWS·August 10, 2021
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020