18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VANGUARD REPROCESSED PULSE OXIMETER SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673167·LEVAMED STABILI-TRI ANK SUP BLU L IV
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040056417·Zirlux Multi Anterior B1,98.5X12
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033380673·
MINIMED MIO ADVANCE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·August 13, 2025
K012364
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015
ADJUSTABLE LARGE FIXATOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
FDA 510(k)
FDA Class 2
·Anesthesiology
STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA Adverse Event
Other
·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·March 20, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code MCX·March 9, 2011
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR GALWAY·Product code NIM·February 12, 2008
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 20, 2015
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019