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

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IDRIVE ULTRA STERILIZATION TRAY

FDA 510(k)
FDA Class 2 ·General Hospital

LEONE SPA

FDA UDI
LEONE SPA·08033707010807·CALIBRA 1ST MOLAR BANDS n.UL 32

Scanner, TxCell Z130/532

FDA UDI
IRIDEX CORPORATION·00813125016364·

INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT

FDA Adverse Event
Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532601·IN-OVATION® C Roncone 022/U5-5 L3-3 CS HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532001·IN-OVATION® C Base Rx 022 U5-5/L3-3

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532611·IN-OVATION® C Roncone 022/U5-5 L3-3 CS-BC HK

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532111·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532101·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS HK

K133532

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·February 2, 2021

VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819

FDA 510(k)
FDA Class 2 ·Orthopedic

CPCA2000 COUNTERPULSATION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 24, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014

CAPSUREFIX

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size 1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component Catalog: 05-01-0033.

FDA Recall
Terminated ·Endotec, Inc.·Product code JWH·June 5, 2009