10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dynamis Pro Family
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
FDA 510(k)
FDA Class 1
·General Hospital
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
FDA 510(k)
FDA Class 2
·Ophthalmic
BD CONNECTA¿ STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·January 2, 2020
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
INTCB INT CB PKGD
FDA Adverse Event
Injury
·CHATTANOOGA GROUP·Product code IPF·October 27, 2008
TARGET¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code HCG·August 16, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
ALIYA
FDA Adverse Event
Injury
·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026
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