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