17 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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Omnia Medical TiBrid-SC
FDA 510(k)
FDA Class 2
·Orthopedic
NuVasive
FDA UDI
Nuvasive, Inc.·00195377105295·NTS Slot Tube, 26x120mm Beveled
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113216826·Intent to be used with suture material for tiss...
Bernafon
FDA UDI
Bernafon AG·05711584114155·CZ9 B 105, 2.4G NFM SABE/MSIL CORAL 9 GPL
meijer
FDA UDI
MEIJER, INC.·00713733521666·Antibacterial Gauze Pad, all one size, 2 IN x 2...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514407·
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383515108·"An absorbent paper points is an endodontic pap...
IntelAir
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071131937·IntelAir, Tape Secured, with O2/CO2 Tubes, 26F ...
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·October 24, 2008
REPLACEMENT HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021