14 results
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36ms
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Sources: EU EUDAMED, US FDA
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