10 results
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35ms
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Sources: EU EUDAMED, US FDA
ANALYZER, MODEL CC-720
FDA 510(k)
FDA Class 2
·Hematology
Trumpf Medical
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761996182·Hospital Device
ReLine
FDA UDI
Nuvasive, Inc.·00887517010629·RELINE-C Gripper, Rod
Trimline
FDA UDI
ORMCO CORPORATION·00889989050981·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 26
Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
FDA 510(k)
FDA Class 2
·Anesthesiology
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
FDA 510(k)
FDA Unclassified
·Unknown
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·May 5, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTUR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·August 2, 2010