18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033401·Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEu...
Phonak
FDA UDI
Phonak AG·07613275359365·Phonak Sky V30-SP (beige)
SPACELABS HEALTHCARE
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522121852·PATIENT CABLE,MICRO-V,PM-3,EU
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 23, 2006
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 20, 2006
DEPUY ASR XL FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 3, 2013
TARGIS SYSTEM
FDA Adverse Event
Malfunction
·UROLOGIX, INC.·Product code MEQ·March 22, 2011
HEPARIN I.V. FLUSH SYRINGE, 100 UNITS/ML
FDA Adverse Event
Injury
·MEDEFIL·Product code NZW·April 23, 2008
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 8, 2005
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016