16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)
FDA 510(k)
FDA Class 2
·Physical Medicine
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199458·Revision Knee Spiral Reamer- Hudson Long Flutes...
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471142943·Patient Ties - Clear
XiVE®
FDA UDI
Dentsply Implants Manufacturing GmbH·EFRI322542002·XiVE® TG Coping Screw
XiVE®
FDA UDI
Dentsply Implants Manufacturing GmbH·07392532223181·XiVE® TG Coping Screw
InbellaBody System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vital Signs
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·May 2, 2002
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008
UNICEL DXC 800
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 19, 2011
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 30, 2013
PERSONA REVISION TAPERED CEMENTED STEM EXTENSION 13MM DIA +75MM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 9, 2023
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·June 19, 2012
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·June 19, 2012
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019