19 results
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26ms
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Sources: EU EUDAMED, US FDA
ABSORBENT ENDODONTIC POINT
FDA 510(k)
FDA Class 1
·Dental
DD cubeY® HL
FDA UDI
Dental Direkt GmbH·EDDIG8430171·The DD cubeY® HL zirconium dioxide milling blan...
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
FDA 510(k)
FDA Unclassified
·Unknown
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Zimmer, Inc.·00889024195165·
VerSys®
FDA UDI
Zimmer, Inc.·00889024136939·
VerSys®
FDA UDI
Zimmer, Inc.·00889024136922·
VerSys®
FDA UDI
Zimmer, Inc.·00889024136915·
VerSys®
FDA UDI
Zimmer, Inc.·00889024136908·
NA
FDA UDI
Zimmer, Inc.·00889024195172·
VerSys®
FDA UDI
Zimmer, Inc.·00889024136892·
VerSys®
FDA UDI
Zimmer, Inc.·00889024136885·
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 13, 2014
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 21, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 23, 2010
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 2, 2016
VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·January 30, 2019
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 2, 2016