21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENCORE 26 ADVANTAGE KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Starbond Easy
FDA UDI
S & S Scheftner GmbH·04260207854288·Powder 45, 5kg
ForPro
FDA UDI
Tng Worldwide, Inc.·00672047000970·Blue Nitrile Exam Gloves
Size Small
100ct
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925016484·TRAPEZE RIBBON LOOP 5 MM LENGTH PLATINUM
SSW CARBIDE
FDA UDI
Ss White Burs, Inc.·D6901407452·FG SL CARBIDE 1702 - 5 PACK
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034307898·Cancellous Screw, Cannulated, D=4.0mm, L=45m
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046336·PrimaLIF LLIF PEEK Implant, 7mm X 26mm X 45mm, ...
PEEK Temporary Abutment
FDA UDI
BICON, LLC·00813110027863·4.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
FDA 510(k)
FDA Class 2
·Cardiovascular
STEM: AMISTEM H HA COATED STD STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 29, 2020
AMISTEM H, HA COATED STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 6, 2017
BD SLIP TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·January 28, 2023
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2014
M2A 38MM MOD HD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 31, 2013
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 15, 2011
AMISTEM H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 22, 2025
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
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013