13 results
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22ms
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Sources: EU EUDAMED, US FDA
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113653·SUB-TENONS CANNULA 19GA 25MM
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133340·LATERAL,SCALPEL,BAYONETTED
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351101304·LAP- Electrode, monop., Ø5mm, l=450mm
Spatul...
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOPSY SITE TISSUE MARKER DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFANT LOW FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·October 17, 2008
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·July 2, 2013
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025