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

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COOK ZILVER BILIARY STENT

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

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776387037·Kawamoto Osteotome, curved, 6 3/4", 10mm

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450135358·

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036007003·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033119556·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0100420·Assembly, Caddie, Adjustable Cross Links

MINIMED MIO ADVANCE

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·July 18, 2025

MINIMED MIO ADVANCE

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·June 6, 2025

ISOLETTE INFANT INCUBATOR, MODEL C2HS

FDA 510(k)
FDA Class 2 ·General Hospital

ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016

TRINKLE QUICK-COUPL DRILLING SPEED MODIF

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

CHOLESTECH

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code CHH·February 11, 2011

LOCKING TABLET CUTTER

FDA Adverse Event
Malfunction ·APOTHECARY PRODUCTS, INC·Product code LDQ·March 8, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·H10·Product code KWP·April 4, 2013

BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

FDA Adverse Event
Malfunction ·SYNTHES SALZBURG·Product code HTD·January 17, 2016

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

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014