36 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIFE SPINE INTERSPINOUS FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Digital Analogue RN
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074390·
BEER DISTICHIA CILIA FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047402·BEER DISTICHIA CILIA FORCEPS TUNGSTEN CARBIDE D...
GLOVER COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004070·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED CURVED
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450158449·
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
FDA 510(k)
FDA Class 2
·Neurology
SUREFIT DUAL DISPERSIVE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
microTargeting™ Digital Display Unit (DDU)
FDA UDI
FHC, INC.·00873263004074·Digital Display Unit forNexDrive with Encoder
TI MATRIXRIB UNIVERSAL PLATE 8 HOLES
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·May 8, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·May 13, 2011
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORHTOPEDICS·Product code KWY·April 6, 2012
36MM COCR MOD HD STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·April 6, 2012
M2A-MAGNUM 42-50MM TPR INSRT-3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 6, 2012
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 6, 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
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples
FDA Enforcement
Class II
·Terminated·Aspen Surgical Products, Inc.·August 28, 2013
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
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024