25 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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