10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KLS Martin Neuro Rongeurs
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319707463·Coronal Brow Lift Retractor 7" (17.5cm), 7 shar...
SCEPTER C OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VOLUSON S6, VOLUSON S8
FDA 510(k)
FDA Class 2
·Radiology
STERRAD NX STERILIZER
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·October 23, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
UNIFY QUADRA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015
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