13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMBOLD Soft Detachable Coil System
FDA 510(k)
FDA Class 2
·Cardiovascular
Zavation
FDA UDI
Zavation LLC·00197157002749·CIF 14x18, 7 deg, -06
DUOFLEX COIL SUITE (1.5T)
FDA 510(k)
FDA Class 2
·Radiology
EBI DYNAFIX COMPRESSION BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
SROM STM ST,36+6L NK,11X16X150
FDA Adverse Event
Injury
·DEPUY IRELAND ¿ REG. # 9616671·Product code LPH·April 11, 2016
S-ROM*SLEEVE PRX ZTT, 16D-LRG
FDA Adverse Event
Injury
·DEPUY IRELAND ¿ REG. # 9616671·Product code LPH·April 11, 2016
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008
SYSTEM 1000
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code KDI·September 1, 2011
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 16, 2013
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024