14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
BELLEGLASS HP OPAQUE 2
FDA 510(k)
FDA Class 2
·Dental
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM
FDA Adverse Event
Malfunction
·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015
CAIMAN DISP INSTR ARTICULAT D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 16, 2014
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·September 16, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 4, 2011
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014
145-DEG PE 36MM HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·December 10, 2024
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