19 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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ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
FDA 510(k)
FDA Class 2
·Dental
Original D Capsules 1 Spill Extra Fast Set 100 caps
FDA UDI
Wykle Research, Inc·00853383006097·
Batrik Suture Tags\Pink\1x3pr.
FDA UDI
Batrik Medical Manufacturing Inc·00690521012448·"Suture Clamp Tags, Radio Opaque, Non-Sterile, ...
10PW - Heba Fire & Safety
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130033·10PW - Heba Fire & Safety
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DISP SNAP Y SET, W/DISINFECT, W/DR BAG
FDA Adverse Event
Injury
·MEDISYSTEMS·Product code KDJ·March 16, 1998
Widex
FDA UDI
Widex A/S·05706069645910·COMPASS GPS V2.2 package (French)
PROGAV®
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 15, 2013
AED10
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·May 25, 2011
GE OEC 7600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 15, 2008
EU 4.5X22MM STENT 12 MM DW TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 4, 2023
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·December 18, 2013
Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems
FDA Enforcement
Class II
·Terminated·GE Healthcare·April 1, 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