17 results · 20ms · Sources: EU EUDAMED, 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