20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIAISON VZV IgG, LIAISON Control VZV IgG
FDA 510(k)
FDA Class 2
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V
Oticon
FDA UDI
Oticon A/S·05707131287656·H10V2, RITE 312 WL CBE
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239036·
UNKNOWN PALACOS CEMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·April 11, 2023
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104354·RAPIDCUT BLADE, 5.5MM, COMPATIBLE W/SN
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
FDA 510(k)
FDA Class 2
·Immunology
BLUESHINE'S GOLD SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102367·DISPOSABLE ARTHROSCOPIC 5.5mm RAPIDCUT SHAVER B...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 6, 2021
PERMANENT PACEMAKER ELECTRODE
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code DTB·August 12, 2023
OSS AVL TIBIAL LOCK RING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·April 14, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 27, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
CENTURY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
UNKNOWN GEL IMPLANTS SMOOTH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 28, 2023
MOD ARTHRO NL 1CM ELIP CNCTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·October 15, 2019
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
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