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

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Dermapose Access

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

ePatch Electrode-patch

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146EPE0·

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776306618·Kelly Retractor 3" x 3.5" w lamb handle

DEBAKEY TISSUE FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060340·DEBAKEY TISSUE FORCEPS MICROSCOPIC ROUND HANDLE...

Ophthalmic Cannula

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

MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Widex

FDA UDI
Widex A/S·05706069305142·RC4 version 2 (Pearl white, no bat )

NIR W/SOX MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION, IRELAND, LTD·Product code MAF·May 17, 2001

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·June 3, 2005

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

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

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·December 9, 2014

CAPSUREFIX

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2011

BIOGLUE SURGICAL ADHESIVE

FDA Adverse Event
Other ·CRYOLIFE, INC.·Product code MFI·September 30, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

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

SMR CEMENTLESS FINNED STEM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code HSD·August 28, 2023

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·July 1, 2020

SLIDING MECHANISM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HTD·February 7, 2024