18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PhantomMSK Hip
FDA 510(k)
FDA Class 2
·Radiology
SOFTSILK
FDA UDI
Smith & Nephew, Inc.·03596010510747·8 X 30 MM SOFTSILK 1.5 SCREW
...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744444·Barsky Nasal Hook 6-1/4" (15.6cm), 2 sharp pron...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118255·MINI LAMBOTTE osteotome,2mm
125 mm,5"
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197118262·MINI LAMBOTTE osteotome,3 mm
125mm,...
RESPICHAMBER VALVED HOLDING CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
EMBRYOGEN
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
Widex
FDA UDI
Widex A/S·05706069827385·WIDEX EVOKE EBB3D (Deep Blue ) 110, Telecoil, R...
Widex
FDA UDI
Widex A/S·05706069914610·WIDEX MOMENT MRB2D (Deep Blue ) 110, Telecoil, ...
ETS FLEX ARTICNG LNR CUTR 45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 20, 2008
COULTER LYSE S III DIFF LYTIC REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GGK·August 5, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)
FDA Adverse Event
Death
·CURRENT HEALTH LTD·Product code MSX·September 9, 2024
LAPIPLASTY SYSTEM S4A
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.
FDA Enforcement
Class II
·Terminated·Integrity Implants Inc.·December 14, 2022
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015