24 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AcQMap 3D Imaging and Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
24PW - Hanta Virus
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101702·E-MAXTM Vitamin E Patella Sz 5 42mm 10.0mm Thick
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101696·E-MAXTM Vitamin E Patella Sz 4 38mm 9.5mm Thick
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101689·E-MAXTM Vitamin E Patella Sz 3 34mm 9.0mm Thick
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101665·E-MAXTM Vitamin E Patella Sz 1 27mm 8.0mm Thick
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101672·E-MAXTM Vitamin E Patella Sz 2 30mm 8.5mm Thick
NORMED BONE TRANSPORT DISTRACTION DEVICE
FDA 510(k)
FDA Class 2
·Dental
DR5000 DEDICATED CHEST X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 15, 2022
SPINAL NEEDLE 27GA 3.50 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MIA·November 28, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 3, 2011
A200 KNEE SYSTEM
FDA Adverse Event
Injury
·RENOVIS SURGICAL TECHNOLOGIES, INC.·Product code JWH·September 16, 2016
A200 KNEE SYSTEM
FDA Adverse Event
Injury
·RENOVIS SURGICAL TECHNOLOGIES, INC.·Product code JWH·September 16, 2016
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025