20 results · 21ms · Sources: EU EUDAMED, US FDA

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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