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