25 results · 22ms · Sources: EU EUDAMED, US FDA

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GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Endo Peanut

FDA UDI
Covidien LP·10884523000764·Blunt Dissector

SILVERMED ANTIMICROBIAL SILVER HYDROGEL

FDA 510(k)
FDA Unclassified ·Unknown

KJ MASK

FDA 510(k)
FDA Class 2 ·Dental

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 18, 2019

MBT CEM TIBIAL TRAY SZ4

FDA Adverse Event
Injury ·9616671 DEPUY IRELAND·Product code NJL·June 17, 2013

STERLING BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 23, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·April 1, 2022

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·April 1, 2022

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·April 1, 2022

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·August 25, 2022

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code LQR·February 3, 2021

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Injury ·COOK INC·Product code LQR·January 8, 2025

N-COMPASS NITINOL STONE EXTRACTOR

FDA Adverse Event
Injury ·COOK INC·Product code LQR·February 10, 2022

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding

FDA Recall
Terminated ·Covidien LLC·Product code GCJ·May 9, 2017

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026