14 results
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28ms
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Sources: EU EUDAMED, US FDA
ANEROID SPHYGMOMANOMETER, DOCTOR TYPE
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746110672·DB BKT MINI MS UL CUSP 018 T-2 A+7 R4M
LEONE SPA
FDA UDI
LEONE SPA·08033707065777·INTRAORAL ELASTICS 6,5 oz 1/8" brown
16PW - Krispy Kreme FAK - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White
MICROSPAN SYSTEM
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code FED·June 8, 2006
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·August 28, 2025
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code NIP·November 12, 2010
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBE·January 3, 2013
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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024