12 results · 35ms · Sources: EU EUDAMED, US FDA

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ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033606·Baltic Denture System BDLoad BDLoad Sm6 PLSEbm...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position

TILITE YG AND TILITE YGS

FDA 510(k)
FDA Class 1 ·Physical Medicine

ACS 180 HOMOCYSTEINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PORTASCAN

FDA Adverse Event
Malfunction ·MEDIWATCH UK LTD·Product code ITX·November 17, 2011

TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·April 3, 2013

HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 11, 2011

ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Injury ·STAAR SURGICAL CO.·Product code HQL·April 24, 2008

McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380

FDA Recall
Terminated ·Inamed Corp·Product code FWM·December 14, 2005

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024