15 results · 30ms · Sources: EU EUDAMED, US FDA

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PulseFlowDF

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321508060·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311508060·

BD¿ STERILE CONVENIENCE TRAYS W/ 10ML LUER-LOK TIP SYRINGES

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 9, 2023

OPTECURE

FDA 510(k)
FDA Class 2 ·Orthopedic

DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·March 10, 2016

PS TIBIAL INSERTS SZ 3, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·May 1, 2023

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·January 20, 2017

JOSTENT GRAFTMASTER

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MAF·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.

FDA Recall
Terminated ·Conmed Electrosurgery·Product code GEI·September 5, 2006

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012