15 results · 23ms · Sources: EU EUDAMED, US FDA

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REPORTING INTEGRATOR 3392A

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CAPIO

FDA UDI
TELEFLEX INCORPORATED·14026704603869·Braided Polyester Green PTFE Impregnated Size 0...

CAPIO

FDA UDI
TELEFLEX INCORPORATED·04026704603862·Braided Polyester Green PTFE Impregnated Size 0...

CAPIO

FDA UDI
TELEFLEX INCORPORATED·14026704713483·Braided Polyester Green PTFE Impregnated Size 0...

KINGTECH FOREHEAD THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HUDSON THERMAGARD NEBULIZER HEATER

FDA Adverse Event
Malfunction ·TELEFLEX·Product code BTT·March 24, 2014

UNKNOWN DEPUY HEAD

FDA Adverse Event
Injury ·DEPUY WARSAW·Product code KWY·November 15, 2012

ALUMINA C-TAPER HEAD 28MM/0

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code LZO·September 9, 2010

COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code GAT·March 27, 2019

TEV GN BR 0 TC-43 2N 48"

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code GAT·December 18, 2017

TEV GN BR 0 TC-43 2N 48"

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code GAT·December 29, 2020

EV3 Pipeline Flex Embolization Device with Flex Shield Technology

FDA Enforcement
Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021