17 results
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21ms
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Sources: EU EUDAMED, US FDA
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·July 12, 2017
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·May 2, 2017
OCTAGON Infinity TL RP Solid abutment yellow, 6°, H 4.0 mm
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50810381·TL RP Solid abutment yellow, 6°, H 4.0 mm for O...
OCTAGON Infinity TL RP Solid abutment yellow, 6°, H 4.0 mm
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·XXXX50810389·TL RP Solid abutment yellow, 6°, H 4.0 mm for O...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609102·GETINGE / SHAMPAINE 5.25" DELUXE GEL
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 38mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025217·
CD38-APC (Clone IB6)
FDA UDI
Miltenyi Biotec B.V. & Co. KG·04049934134210·IB6 recognizes the human CD38 antigen, a single...
TAPER-LOCK DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
GC ELITE CEMENT 100
FDA 510(k)
FDA Class 2
·Dental
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 4, 2025
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 26, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 14, 2011
7.0MM TI USS VARIABLE AXIS SCREW 45MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWP·July 18, 2008
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-08103. 8 mm x 100 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions
FDA Recall
Terminated
·Boston Scientific Corporation·Product code NIP·May 19, 2011
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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