22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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