10 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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ASTRA TECH IMPLANTS-DENTAL SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515242074·Replacement Ebonized set screw for items 93-176...
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MENTOR OBTAPE TRANS-OBTURATOR TAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
DIMENSION® XPAND PLUS WITH HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD·Product code MMI·January 28, 2013
ZYDERM 1 COLLAGEN IMPALNT (1.0ML)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LMH·November 22, 2010
XPANDER IBT
FDA Adverse Event
Malfunction
·KYPHON NEUCHATEL·Product code HRX·July 14, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024