16 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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Shani Darden LED light therapy mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Medos International Sàrl·10886705003440·REUSABLE OBTURATOR 5.5 x 55mm
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114390·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 X...
SCANLAN® V.I.P™ Instrument Sterilization Trays
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008227·Metal Sterilization Tray
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857522275·Trial Size 13x16x10 mm, 12°
PIN GUIDE
FDA UDI
Biomet Orthopedics, LLC·00887868024016·
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 30, 2023
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
FDA 510(k)
FDA Class 2
·General Hospital
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RAVINE® Lateral Access System
FDA UDI
VB Spine LLC·10888857214941·ACDF PIN, Size 40 mm
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 24, 2008
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Other
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 18, 2011
DUROM US ACETABULAR COMPONENT 56/50 P
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·July 3, 2013
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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
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