20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
HAMILTON-C1
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·January 29, 2025
LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 4 Hole, Left
FDA UDI
Bonebridge AG·07640187462784·
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122261·Kwire .062x6" (1.6x150mm) Threaded
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122278·KWire .062x6" (1.6x150mm)
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108123·CASTROVIEJO NEEDLE HOLDER DELICATE STR
Cervical Interbody 15mm x 13mm x 10mm
FDA UDI
XENCO MEDICAL LLC·B064XM21615101·
15mm X 13mm X 10mm CERVICAL INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XM31615101·
15mm X 13mm X 10mm CERVICAL INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XMPH31615101·
eTRAX™ Needle
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103418·Sterile needle, 16GA x 15cm with (7.6 tapered t...
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78816151000101·EXL 018/U1&2 60T 0A
SANARUS VISICA TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 14, 2011
RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·September 15, 2008
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 24, 2020
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·August 17, 2016