23 results · 36ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ECG Monitor App

FDA 510(k)
FDA Class 2 ·Cardiovascular

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433880·Integra® Jarit® Kelly Retractor, 10-1/2", Hollo...

24M - Nevada Energy - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA

LIPOSUCTION CANNULA

FDA UDI
SONTEC INSTRUMENTS, INC.·B0992011680·LIPOSUCTION CANNULA COBRA

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821509·Halpern Breast Caliper, 38mm

LEGEND POWER ADAPTER MODEL: 6475000

FDA 510(k)
FDA Class 2 ·Neurology

JUMP START, MODEL 970300

FDA 510(k)
FDA Class 3 ·Cardiovascular

ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·October 31, 2018

NUROLON NYLON SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAR·October 31, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·July 3, 2020

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Enforcement
Class II ·Terminated·Anodyne Surgical·June 23, 2021

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

HICKMAN

FDA Adverse Event
Malfunction ·C.R. BARD, INC.·Product code LJS·April 8, 2013

T-LINK DATA MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·July 29, 2011

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Recall
Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021

BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020