19 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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syngo.CT Myocardial Perfusion
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131281593·NERA2, BTE 13 WL 100 CNB
BA-1507-13
FDA UDI
PATHEN MEDICAL LLC·00850005864516·Administration set W/Spike, 150 Micron filter w...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100202·NEVYAS DRAPE SPECULUM OPEN WIRE
Bonding Accessories
FDA UDI
TP ORTHODONTICS INC·00192029000243·ADHESIVE, BRACKET-Tooth Conditioner, Resin
WATERPAP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
FDA 510(k)
FDA Class 2
·Immunology
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·January 7, 2016
STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 10, 2025
MISAGO RX Self Expanding Peripheral Stem
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 7, 2016
STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·August 22, 2025
NAV STRAIGHT CUP POSITIONER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·June 6, 2013
G2 FILTER SYSTEM - FILTER
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·June 24, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·May 24, 2016
CLAMPING FOOT FOR 328.040 LCP 3.5MM AND LC-DCP 3.5MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·March 17, 2020