13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cannulated Fasteners and Nuts
FDA 510(k)
FDA Class 2
·Orthopedic
PosiSep C
FDA UDI
HEMOSTASIS, LLC·00858439001385·PosiSep C devices are patient-comfortable spong...
ACUFEX
FDA UDI
Smith & Nephew, Inc.·03596010527271·MTO MICRO PUNCH DOWN SWEPT 10 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133890·LATERAL,HALF INCH COBB,WELDMENT
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319745137·Yancoskie Abdominoplasty Retractor 7-1/2" (18.8...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·10884450414559·
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NURSE'S ASSISTANT O.R. CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARDIAMOBILE
FDA Adverse Event
Malfunction
·ALIVECOR·Product code DPS·January 24, 2022
MENTOR
FDA Adverse Event
Malfunction
·INAMED CORP·Product code FWM·October 20, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015