19 results · 19ms · Sources: EU EUDAMED, US FDA

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READYSWIM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890113460·Zirlux Titanium Screw compatible with: Strauman...

Sanibel Supply A/S

FDA UDI
Interacoustics A/S·05711117019025·ETB standard electrode cable kit/5pcs (BRWYB), ...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450218433·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278536·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278512·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278543·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278529·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278499·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033278505·

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

FDA 510(k)
FDA Class 2 ·Cardiovascular

KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR

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

VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HRS·March 19, 2013

ALTRX +4 10D 36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 4, 2011

TAXUS EXPRESS2 PALITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·March 11, 2008

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024