34 results · 29ms · Sources: EU EUDAMED, 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