22 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Unity Total Knee System
FDA UDI
CORIN LTD·05056139243783·UNITY KNEE™ PS-C INSERT - Size 6 x 9mm
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037308530·TRIAL HUMERAL CUP 135/145° MOBILITY Ø32 +9
ZAVATION F3D-Z CIF
FDA UDI
Zavation LLC·00197157020477·F3D-Z CIF 14mmx16mmx9mm -6 deg
BONASTENT® Tracheal/Bronchial
FDA UDI
Sewoon Medical Co., Ltd.·08806369468428·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160473·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383505680·Gutta Percha Points is used to root canal filin...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857551282·Offset Blade Right Size 120 mm
Zavation
FDA UDI
Zavation LLC·00842166188136·Custom PLIF SIZER
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018135·Wide Jaw Punch medium 15 degree up milled 3.5mm...
EPIDUCER LEAD DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
10.25 X 64MM, 3.0ML BD VACUTAINER® ACD GLASS TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·June 2, 2017
PERMACOL 10X15 1.5MM
FDA Adverse Event
Death
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·September 9, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 10, 2011
PULMONETIC
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 203 / PULMONETIC SYSTEMS, INC.·Product code CBK·August 13, 2008
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill
FDA Enforcement
Class II
·Ongoing·Certified Safety Mfg Inc·May 18, 2022