14 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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Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
FDA 510(k)
FDA Class 2
·General Hospital
ScrewPlus® Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105589·3.7mmD x 13mmL, 3.7mmD Platform
RIGIDFIX
FDA UDI
Medos International Sàrl·20886705020000·RIGIDFIX CURVE ST ACL PLA Cross Pin System (2) ...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100869·EVOS Straight HA PEEK, 13mm x 8mm x 26mm, Flat ...
Surge Cardiovascular
FDA UDI
Med Michigan Holdings, LLC·00817278010026·Curved Suture Guide, 3 Pack
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130130·Sagittal Bender, Left
ENDOSCOPIC INTRODUCER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
FDA 510(k)
FDA Class 2
·Cardiovascular
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 12, 2011
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·September 1, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
SAVVY PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LIT·October 3, 2013
RGDFX CRVE ST ACL PLA XPIN SYS
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HTY·June 5, 2018
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