11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ultrasonic Scalpel System
FDA 510(k)
FDA Unclassified
·Unknown
Bernafon
FDA UDI
Bernafon AG·05711584114179·CZ7 B 105, 2.4G NFM SABE/MAC CORAL 7 GPL
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113216765·Intent to be used with suture material for tiss...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383515122·"An absorbent paper points is an endodontic pap...
IntelAir
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071131951·IntelAir, Tape Secured, with O2/CO2 Tubes, 26F ...
KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
FDA 510(k)
FDA Class 2
·Cardiovascular
VINTAGE MP PRESS OVER
FDA 510(k)
FDA Class 2
·Dental
HAKIM INLINE PROGRAMMABLE VALVE SG
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./ MEDOS S.A.·Product code JXG·October 24, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·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