9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bernafon
FDA UDI
Bernafon AG·05711584115022·CZ5 MNR, 2.4G NFM SABE/MAC CORAL 5 GPL
RESPIRONICS HEATED HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
TOXCUP DRUG SCREEN CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·April 8, 2020
SMARTSET HV BONE CEMENT 40G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·October 24, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 11, 2011
PUNCTUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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