19 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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ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Implant and Instrument Set 7.0mm
FDA UDI
ORTHO OUTCOMES, LLC·00850072364001·Bone Bolt System Implant and Instrument Set 7.0mm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735473·Nail Scissors 3-1/2" (8.8cm), curved blades, ch...
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291105466·SS Suture, 2 per sleeve
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"
Toilet Support Arms
FDA UDI
Ropox A/S·05707581004247·
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 26, 2024
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400404250·C & B FORMULA 4 OZ SHADE 25
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·April 3, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP·Product code CBK·May 7, 2008
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·April 5, 2011
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·January 7, 2015
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024