17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultrasonic Osteotomy Surgical System
FDA 510(k)
FDA Class 2
·Orthopedic
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·May 2, 2018
36M - Navajo Tribal Utility Authority
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority
Navajo Tribal Utility Authority - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992012740·LIPOSUCTION CANNULA MERCEDES STYLE
Liposuction Cannula
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896108080·Liposuction Cannula Mercedes Style 220 X 3 Mill...
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
FDA 510(k)
FDA Class 2
·General Hospital
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·August 15, 2013
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 27, 2015
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·February 24, 2016
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 27, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 3, 2011
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 2, 2013
HEMOPRO 2 ADAPTOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020