11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EUTROCHAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Equate
FDA UDI
WAL-MART STORES, INC.·00194346498253·
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496050957·RED WELLNESS 70 OPAQUE, SIZE M, FOREST, GRADUAT...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450310045·
HOFFMANN II EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
QUELL DESENSITIZER
FDA 510(k)
FDA Class 2
·Dental
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·April 10, 2013
MICRUS MICROCOIL SYSTEM
FDA Adverse Event
Injury
·MICRUS ENDOVASCULAR CORPORATION·Product code MJN·April 4, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018