17 results · 22ms · Sources: EU EUDAMED, 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