14 results · 28ms · Sources: EU EUDAMED, US FDA

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INFRARED SCIENCES BREASTSCAN IR SYSTEM

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032350·Baltic Denture System BDLoad Mn7 PLSEbim6DFm A3...

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120323501·Diamond, torpedo, COOL DIAMANT, coarse grit, gr...

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102534·KNOLLE LENS NUCLEUS SPATULA

GE PARALLEL DESIGN, INC.

FDA registration
GE PARALLEL DESIGN, INC.·7 products·🇺🇸 United States

REFACTO LABORATORY STANDARD

FDA 510(k)
FDA Class 2 ·Hematology

MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 6, 2025

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 29, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 22, 2011

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIQ·April 22, 2008

ACCUVUE ADVANCE

FDA Adverse Event
Injury ·VISTAKON·Product code LPL·October 19, 2007

Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012