24 results · 34ms · Sources: EU EUDAMED, US FDA

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SEA-LINK Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777662·LUMBAMED BASIC DORSAL STAYS M SILVER IV

Waterlase Laser Tips

FDA UDI
Biolase, Inc.·00647529000922·A single-use fiberoptic accessory intended for ...

OPERATING SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054592·OPERATING SCISSORS CURVED BLUNT TIPS POWER CUT ...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694006347·Rigid Nose Mini Plate Benders

FLUROPERM 60-OK, PARAGON HDS-OK

FDA 510(k)
FDA Class 2 ·Ophthalmic

ESTECH COBRA BIPOLSR II

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 23, 2022

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·March 29, 2016

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·December 16, 2020

DRILL, 1.5X105MM, 22MM STOP, J NOTC

FDA Adverse Event
Other ·BIOMET MICROFIXATION·Product code HTW·October 2, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 1, 2013

PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·August 30, 2019

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 22, 2016

SMR SHOULDER

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code MBF·December 7, 2023

NEEDLE 25GA 1IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·August 27, 2021

SYNVISC (HYLAN G-F 20) INJECTION

FDA Adverse Event
Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013

SYNVISC (HYLAN G-F 20) INJECTION

FDA Adverse Event
Other ·GENZYME BIOSURGERY·Product code MOZ·April 25, 2013

Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

FDA Enforcement
Class II ·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024