11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASCENT KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
artegral life
FDA UDI
Merz Dental GmbH·D7091993111·anteriors; shade A3.5; mould BIS
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198093·AK3 PS Insert Trial Size 1, 11mm
LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MIKRO-CATH, MODEL 825-0101
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·March 15, 2023
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 1, 2013
PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 16, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
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
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026