16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814732·GENUMEDI EXTRA WIDE SAND SIZE V
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964024441·The ENDO CARRY-ON Procedure Kit contains all of...
DC ZIRKON
FDA 510(k)
FDA Class 2
·Dental
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
FDA 510(k)
FDA Class 2
·Cardiovascular
SECURE FLOW
FDA Adverse Event
Injury
·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012
M2A 38MM MOD HD+9MM NK NO SKRT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 17, 2013
M2A 38MM MOD HD -6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 17, 2013
DERMABOND 2
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MPN·March 14, 2013
ZIMMER M/L TAPER MODULAR FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·February 24, 2011
COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JDC·February 26, 2008
M2A-38 CUP NON FLARED SZ 60MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 17, 2013
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018