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