9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EP MEDSYSTEMS, EP-WORKMATE
FDA 510(k)
FDA Class 2
·Cardiovascular
NANOHYBRID COMPULES 15-.3 Gm (A4)
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77819940111·Nanohybrid Composite contains a new ytterbium f...
MODEL #527 OPHTHALMIC STRETCHER
FDA 510(k)
FDA Class 2
·General Hospital
TOTAL GALACTOSE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 31, 2025
SYNFIX-LR 26MM DEPTH/32MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MAX·February 27, 2013
U0707 TINA SINGLE PUMP NIBPLCD
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDI·February 16, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F; 6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G; 7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F; 8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K; 9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H; 10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM; 11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D; 12) AV GRAFT RCH 0246952, MODEL/ITEM NUMBER RCAV40C; 13) OPEN HEART PART 1 RCH 0247159, MODEL/ITEM NUMBER RCOH61G; 14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T; 15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM; 16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD; 17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF; 18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH; 19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN; 20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S; 21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q; 22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL; 23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J; 24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E; 25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E; 26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F; 27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025