12 results
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20ms
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Sources: EU EUDAMED, US FDA
AIR PRESS MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032505·Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl C...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746161452·DB BKT MINI MS UR BIC 022 T=0 A=0 R=0
ACE Surgical Ch Gut 3-0 30" Hr26
FDA UDI
Surgical Specialties México, S. de R.L. de C.V.·00848782023059·003-2505 Ch Gut 3-0 30" Hr26
SOPRO595 INTRA ORAL CAMERA
FDA 510(k)
FDA Class 1
·Dental
XIA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST JUDE MEDICAL NEUROMODULATION·Product code LGW·April 1, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 24, 2011
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
C.R. BARD, INC. (BASD)·Product code KNT·April 17, 2008
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.
FDA Recall
Terminated
·Diamedix Corporation·Product code LIP·September 11, 2003
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
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