11 results · 27ms · Sources: EU EUDAMED, US FDA

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MCT-DIABETES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

WAVEWRITER ALPHA? 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 12, 2025

CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MEDIVISION IGS SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

WAVEWRITER ALPHA? PRIME 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 13, 2025

LAVA C.O.S. POWDER

FDA Adverse Event
Injury ·3M ESPE DENTAL PRODUCTS·Product code NOF·March 16, 2012

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 23, 2013

4 HOLE ELONGATE STABILIZER 2PK

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·May 2, 2011

NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX FEMORAL

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HSA·July 1, 2008

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 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