13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HEXIDIS ALCOHOL SWAB
FDA 510(k)
FDA Unclassified
·Unknown
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909107352·REVELATION DIAMOND 858-016M - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112281·SURG-I-BAND GREY
TANDA MAX OTC SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPEEDYBELL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1910735-2001-00002
FDA Adverse Event
Other
·Product code GFD·September 5, 2001
DELTAXSFT10 2MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·February 11, 2022
VANGUARD CR FEMORAL COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·November 23, 2010
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·July 2, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 4, 2012
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025
GENESIS UNI KNEE FEMORAL COMPONENT COCR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024