420 results
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
FDA Enforcement
Class II
·Terminated·CSA Medical·April 29, 2015
Dimension Vista¿ HbA1c
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 5, 2014
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
FDA Enforcement
Class II
·Terminated·CSA Medical·January 14, 2015
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.
FDA Enforcement
Class II
·Terminated·Volcano Corporation·September 19, 2012
Diagnostic Kit SARS-cCo V Antigen Rapid Test
FDA Enforcement
Class II
·Ongoing·USA Medical, LLC·May 18, 2022
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
FDA Enforcement
Class II
·Terminated·Brasseler USA, Medical L.L.C.·March 9, 2022
MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.
FDA Enforcement
Class II
·Terminated·Medminder Systems, Inc.·June 15, 2022
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·July 12, 2023
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·July 12, 2023
Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 22, 2023
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 22, 2023
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·September 23, 2015
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024