22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746101397·DB BRACKET MASTER SERIES MAND 1ST BICUSPID 022 ...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746094125·DB BRACKET MASTER SERIES MAND RIGHT/LEFT 1ST BI...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746096983·DB BKT MASTER IBD LR CUSP 022 T-11 A+7 R=0
Stryker F1
FDA UDI
STRYKER CORPORATION·07613327071979·Oscillating Saw
AQUANET, MODEL EC 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010
FDA 510(k)
FDA Class 2
·General Hospital
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·February 7, 2024
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 27, 2014
PUMP MMT-715LNAL PRDGM INS V2.1 CL EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·November 8, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 26, 2012
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·October 26, 2023
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Recall
Completed
·Empowered Diagnostics LLC·Product code QKP·December 22, 2021
DELTA PROTRUDED LINER INT 32MM #M
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·May 20, 2021
STEM: AMISTEM C CEMENTED LAT STEM SIZE 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 25, 2022
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 15, 2016
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Enforcement
Class I
·Completed·Empowered Diagnostics LLC·February 9, 2022
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 25, 2018
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·May 21, 2018