20 results
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30ms
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Sources: EU EUDAMED, US FDA
OPTICAL GUIDANCE PLATFORM
FDA 510(k)
FDA Class 2
·Radiology
Closed Wound Suction
FDA UDI
C. R. Bard, Inc.·00801741049644·100cc Silicone Closed Wound Suction Evacuator K...
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
NOBELACTIVE INTERNAL RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
MTP LAPAROMAT DISPOSABLE TUBING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIGNUM
FDA 510(k)
FDA Class 2
·Dental
MAX PRI DCM TIB BRNG12X63/67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 22, 2013
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·July 7, 2008
UNKNOWN DEPUY PFC 10MM CURVED INSERT SZ 4
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 13, 2011
RELIAVAC CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFL
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GCY·February 9, 2018
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·July 2, 2014
HAHN TAPERED 4.3 X 11.5MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 1, 2022
HAHN TAPERED 4.3 X 11.5MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 1, 2022
HAHN TAPERED 4.3 X 11.5MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 1, 2022
HAHN TAPERED 4.3 X 11.5MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 1, 2022
HAHN TAPERED 4.3 X 11.5MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 1, 2022
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
FDA Enforcement
Class II
·Terminated·ArthroCare Medical Corporation·December 17, 2014
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
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