20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
OptiScanner 5000 Glucose Monitoring System
FDA 510(k)
FDA Class 2
·General Hospital
Pinehurst Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030728·
Aquila Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125783·
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331120978·Slotted "U" Bracket, 10mm, 1.5"
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776020132·Slotted U Bracket
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776116002·Slotted U Bracket
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138449·Broach, 42 X 32, 13mm Height 16° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138487·Broach, 42 X 32, 21mm Height 16° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138463·Broach, 42 X 32, 17mm Height 16° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138456·Broach, 42 X 32, 15mm Height 16° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138470·Broach, 42 X 32, 19mm Height 16° Hyperlordotic
KINGYIELD WRIST BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
FDA 510(k)
FDA Unclassified
·Unknown
ANSPACH® XMAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 10, 2014
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·July 12, 2011
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 11, 2013
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024