34 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sledgehammer
FDA UDI
Keystone Industries·H66810005401·SC 5 lb Pwd & 1 Qt Liq Kit, Lt Fibered
DAAVLIN
FDA UDI
DAAVLIN DISTRIBUTING CO., THE·B280A0005400·LEVIA, NB UVB
GeneXpert Infinity-48s System
FDA UDI
CEPHEID·07332940004316·Additional catalog numbers: 900-0540L, 900-0540R
BARD TIGER GUIDEWIRE MODEL 000540
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Non-Telescopic PenEvac
FDA UDI
I.C. MEDICAL, INC.·00817688022008·
PedFuse
FDA UDI
SPINEFRONTIER, INC.·00190361022978·PedFuse ReTurn, Hex, CNL, 5.0mm x 40mm
PedFlex Flexible Nailing System
FDA UDI
ORTHOPEDIATRICS CORP.·00841132119648·ø4.0mm x 450mm Round Tip Flexible IM Nail
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 23, 2025
PedFlex Flexible Nailing System
FDA UDI
ORTHOPEDIATRICS CORP.·00841132198315·Ø4.0 MM X 450 MM ROUND TIP FLEXIBLE IM NAIL
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 23, 2025
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLINI-DENT
FDA 510(k)
FDA Class 1
·Dental
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·June 24, 2024
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD·Product code FTL·October 8, 2013
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Death
·EV3 NEUROVASCULAR·Product code OUT·March 12, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 24, 2011
XIA II PA SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code HXX·February 15, 2008
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·September 30, 2021
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·May 9, 2018