23 results · 30ms · Sources: EU EUDAMED, US FDA

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ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT

FDA 510(k)
FDA Class 1 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814640·GENUMEDI SILVER SIZE I

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664009168·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...

CRYOPEN CRYOSURGICAL SYSTEM, K102214

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·June 1, 2023

DEPUY ASR XL FEM IMP SIZE 43

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 19, 2014

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·May 19, 2011

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·June 7, 2022

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·December 7, 2021

PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·February 13, 2024

XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code NIQ·March 31, 2022

I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021