20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TLS 5.0
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CK2212140·Enhanced Graft Interbody Cage 7DEG x 22L x 12W ...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016692·ROD CONNECTOR, PARALLEL SIDE LOADING 14mm offse...
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
t:slim X2 Insulin Pump with Interoperable Technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 21, 2022
ACUVUE ADVANCE WITH HYDRACLEAR
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·November 5, 2008
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 24, 2011
AMPLATZ SUPER STIFF GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·July 11, 2013
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 11, 2015
Philips IntelliSpace Cardiovascular software, Model 830089.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·March 12, 2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·May 14, 2025
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
FDA Enforcement
Class II
·Ongoing·Diasorin Inc.·December 18, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020