19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Smart double sides wearable breast pump, Electric bilateral breast pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEONE SPA
FDA UDI
LEONE SPA·08033707096269·GO T01 OPEN HOOK ANT LONG 200g
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LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481125058·F-Tx Attachment System, Neodent CM Connection, ...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481125171·LOCATOR R-Tx Attachment System, Neodent CM Conn...
Halyard
FDA UDI
O&M HALYARD, INC.·10680651423013·HALYARD* Standard Back Table Cover-No-44 x 88-4...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183525·Integra® Jarit® Luer Rongeur, 7-1/4", 8.6mm Bit...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481129452·LOCATOR R-Tx Abutment, Neodent CM Connection, 2...
BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GBX·July 11, 2025
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MIS Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GBX·July 11, 2025
SPINNING SPIROS® CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·August 10, 2022
VENTRACOR
FDA Adverse Event
Injury
·Product code DSQ·November 12, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 31, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·July 16, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·February 11, 2026
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·July 24, 2024
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017