24 results · 20ms · Sources: EU EUDAMED, US FDA

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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