16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CLEARCORRECT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304554191·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868267680·
7400 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021263·7400 M W/2700 WITH HG
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 15, 2021
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GLADIATOR¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 6, 2012
INDIGO SYSTEM ASPIRATION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code DXE·August 11, 2020
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014
SOFPORT ADVANCED OPTIC LENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQL·May 9, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 24, 2011
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
FDA Recall
Terminated
·Biomet, Inc.·Product code MBF·January 7, 2022
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
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