13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANSPACH LUBRICATING SYSTEM II
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
artegral
FDA UDI
Merz Dental GmbH·D7091970530·anteriors; shade BL3; mould BOM
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665585905·MIS Fenestrated Screw, Ø10.5 x 30mm, Ø6.0mm Rod
MODIFICATION TO PASSMED SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Butrex Lumbar Buttress Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 10, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 20, 2013
ROTICULATOR ENDO GPASP 5MM W/SPIN LOCK
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GET·January 19, 2011
Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
AFFIXUS HFN 130 DEG 11MM X 180MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 22, 2018
RGX 3 PEG SER A PATELLA 37MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 7, 2023
AFFIXUS HFN 130 DEG 11MM X 180MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 22, 2018
BIOMET FINNED PRI STEM 40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 8, 2023