14 results · 28ms · Sources: EU EUDAMED, US FDA

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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