14 results · 36ms · Sources: EU EUDAMED, US FDA

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IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA

FDA 510(k)
FDA Class 2 ·Immunology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496032571·MARILYN 140 SHEER, SIZE ML, GLACE, GRADUATED CO...

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032571·Baltic Denture System BDLoad ↓ Mw6 PLSEum2DFm C...

MULITPLE MALE LATX CONDOM

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

REPROCESSED HARMONIC

FDA 510(k)
FDA Unclassified ·Unknown

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 3, 2013

LOW PROFILE CROSSLINK SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 30, 2015

RENAISSANCE 26 STRETCHR 11/00

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 3, 2013

PROSTHESIS, PENILE, AMS 18CM ULTREX

FDA Adverse Event
AMERICAN MEDICAL SYSTEMS·Product code FHW·March 11, 2011

MULTI-LINK MINI VISION

FDA Adverse Event
ABBOTT VASCULAR DEVICES·Product code MAF·March 27, 2008

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code DQX·July 21, 2021

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

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

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018