14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORUM
FDA 510(k)
FDA Class 2
·Radiology
Stryker
FDA UDI
Provision·B504OM2135270·
XN CAL
FDA UDI
SYSMEX CORPORATION·14987562460325·XN CAL 1X3.0ML
NA
FDA UDI
MAKO SURGICAL CORP.·07613327412376·BONE PINS (3.2MM X 140MM)
BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 31, 2019
BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·February 26, 2020
BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 23, 2019
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
OPTICAGE INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 25, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 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