34 results · 22ms · Sources: EU EUDAMED, US FDA

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GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Bur PM2-95 80K Steel Ø5.0 St

FDA UDI
Bien-Air Surgery SA·17630055504064·

Bur PM2-95 80K steel Ø5.0mm sterile

FDA UDI
Bien-Air Surgery SA·J00711004510011·

Digital Analogue NP

FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074802·

TAYLOR-DINGMAN BONE CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047549·TAYLOR-DINGMAN BONE CLAMP WITH SPEED LOCK

Indus®

FDA UDI
SPINEFRONTIER, INC.·00190361001188·Invue Max, Two Level ACP, 51mm

IN-OVATION® Czr

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807H100451001·IN-OVATION® CZR Base Rx .018 LL5 -22T -1A 4D

IN-OVATION® Czr

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807H100451101·IN-OVATION® CZR Base Rx .018 LL5 -22T -1A 4D HK

NA

FDA UDI
STRYKER CORPORATION·04546540068347·Cordless Driver Sterilization Container

FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NOVAMETRIX MARQUETTE COMPATIBLE SENSORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 28, 2025

TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012

V.A.C. GRANUFOAM DRESSING

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 8, 2013

LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·September 19, 2014

8800

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·May 13, 2011

Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

FDA Enforcement
Class I ·Terminated·Ventlab Corporation·November 7, 2012

Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012

Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015