12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NMF004A
FDA 510(k)
FDA Class 2
·Dental
ANA 2000 Capsules 3 Spill 450 count
FDA UDI
Wykle Research, Inc·00853383006790·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668108956·AIR INJECTION CANNULA 30GA
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702463446·Elvarex 3/Thigh High/Slant, Open Toe, E-Version...
BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 11, 2018
GORE EMBOLIC FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACTIVE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
XLD 11OV L.A. REF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2011
SINGLE USE LIGATING DEVICE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code MND·June 12, 2013
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 8, 2023
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 23, 2020