18 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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Project E Beauty LED Light Therapy Mask (Model: PE730)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DePuy Mitek
FDA UDI
Provision·B504OM2141010·
CHIA PERCPASSER
FDA UDI
Medos International Sàrl·10886705003433·CHIA PERCPASSER Suture Passer
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114376·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 L...
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857522251·Trial Size 13x16x8 mm, 12°
TIBIAL INTRA-OP TEMPLATE
FDA UDI
Biomet Orthopedics, LLC·00887868023965·
FEMORAL INTRA-OP TEMPLATE
FDA UDI
Biomet Orthopedics, LLC·00887868023958·
RAPIDONE-OXY TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
American-Made Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857171596·MESA®Mini 90° Screw Inserter
RAVINE® Lateral Access System
FDA UDI
VB Spine LLC·10888857214927·ACDF PIN, Size 30 mm
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 6, 2012
SMARTSOTE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·August 6, 2014
SYNVISC ONE (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·July 18, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012