14 results
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29ms
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Sources: EU EUDAMED, US FDA
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BASE
FDA UDI
Nuvasive, Inc.·00887517700490·BASE Guide, K
Guided Reamer
FDA UDI
BICON, LLC·00813110026545·5.0 x 11.0mm Guided Reamer
RUMI II KOH-EFFICIENT
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·October 20, 2022
Full Automatic (NIBP)Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
ATRIUM MEDICAL CORPORATION C-QUR MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ANGIOCATH¿ IV CATHETER 22 G X 1"
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·September 13, 2017
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 4, 2022
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 3, 2022
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL NEUROMODULATION·Product code GZB·June 19, 2014
CRW BIOPSY PLUS
FDA Adverse Event
Injury
·INTEGRA BURLINGTON, MA, INC.·Product code HAW·February 6, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CLONMEL IRELAND·Product code NVZ·January 6, 2011
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FOZ·August 8, 2017
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025