16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
FDA 510(k)
FDA Class 2
·Anesthesiology
MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANC
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·July 5, 2019
XPAND RADIOLUCENT CORPECTOMY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
SYSTEM 6 PRECISION HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 30, 2011
CENTRICITY RA1000
FDA Adverse Event
Malfunction
·GE HEALTHCARE INTEGRATED IT SOLUTIONS·Product code LLZ·September 1, 2008
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·December 16, 2022
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·April 17, 2019
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·September 3, 2019
MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·March 29, 2018
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·September 2, 2019
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·September 20, 2018
MECTALIF ANTERIOR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·May 6, 2025
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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024