37 results
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20ms
·
Sources: EU EUDAMED, US FDA
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Digital Analogue SP
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074468·
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989027051·TMA BROAD ARCH UP LGE 0210 0250 PK/10
GLOVER COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004150·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED STRAIGHT
NeuroPlus™
FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·50813150020911·Disposable Medical Electrodes
5 per pouch, 60...
IRIS TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896093973·IRIS TISSUE FORCEPS HALF CURVED TIP
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 21, 2021
ISODAN
FDA 510(k)
FDA Class 2
·Dental
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
REUSABLE ADULT CIRCUIT TUBING
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZO·September 15, 2010
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 26, 2022
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014
ADULT DUAL-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 27, 2010
PULSE GEN MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·May 8, 2013
LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 130°
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·September 19, 2014
ENTRAK 2500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·May 13, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 12, 2015
General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014