11 results · 21ms · Sources: EU EUDAMED, US FDA

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OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

FDA 510(k)
FDA Class 2 ·Ophthalmic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810057370137·GETINGE / SHAMPAINE 5" SOFTCARE

WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CEDIA DAU 6-ACETYLMORPHINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 19, 2024

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC·Product code OTN·April 26, 2013

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

FDA Adverse Event
Injury ·COSTA RICA·Product code LTI·July 23, 2008

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

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