62 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·February 26, 2020
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Enforcement
Class III
·Terminated·Randox Laboratories, Limited·August 14, 2019
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·November 6, 2013
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Enforcement
Class II
·Ongoing·PATH·December 24, 2025
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·December 30, 2020
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
FDA Enforcement
Class II
·Terminated·Impac Medical Systems Inc·July 18, 2012
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
FDA Enforcement
Class III
·Terminated·Theralase Inc.·February 26, 2020
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
FDA Enforcement
Class III
·Terminated·Maquet Cardiovascular Us Sales, Llc·September 23, 2020
a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
FDA Enforcement
Class II
·Terminated·Orthosensor·October 31, 2012
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023
Philips HeartStart FRx AED.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corp.·May 30, 2018
Philips HeartStart (HS1) Onsite/Home AED
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corp.·May 30, 2018
The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.
FDA Enforcement
Class II
·Terminated·Steris Corporation·August 8, 2012
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
FDA Enforcement
Class II
·Ongoing·Oxoid Australia Pty Limited·April 8, 2026
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
FDA Enforcement
Class I
·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025