10 results
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19ms
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Sources: EU EUDAMED, US FDA
ENZYGNOST ANTI-CMV/IGG + IGM
FDA 510(k)
FDA Class 2
·Microbiology
MOR Implant 2.4 x 15mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108211·The MOR is a self-tapping, small diameter, scre...
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020312·Fixed Curve Quadripolar Catheter, Multi-Purpose...
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
FDA 510(k)
FDA Class 2
·Dental
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
HUDSON SHERIDAN/HVT TRACHEAL TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·January 3, 2013
ENDO GIA ROTICULATOR 60-3.5 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·November 11, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
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 UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019