22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Comprehensive Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
HANDLE ACETABULAR PRESS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025
ACETABULAR PRESSURIZER SMALL
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009928·3.0mm x 38mm Cannulated Lag Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694071321·Cannulated 3.0 x 38mm Lag Screw Sterile Qty 5
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
DUET DRF
FDA 510(k)
FDA Class 2
·Radiology
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·February 12, 2020
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
ADVANTAGE SERIES 29 OBS10/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 27, 2013
MTS ABD/ABD MONOCLONAL BLOOD GROUPING CARD
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·August 5, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·CORIN AUSTRALIA PTY LTD·Product code LZO·December 9, 2019