16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KESTREL POSTERIOR CERVICAL SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613115210·WIRE TWISTER JAWS HAVE TC (USE WITH STERNAL NEE...
NexxZr™ T / D-100-10-NT-C300-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113320·
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981200800·Interbody, 11mm x 32mm x 12mm, 20 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981192815·Interbody, 11mm x 32mm x 12mm, 20 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981207922·Trial, 11mm x 32mm x 12mm, 20 deg
MAYO-HEGAR NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896021877·MAYO-HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRA...
AUDIT MICROCONTROLS MICROFD BNP CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
FDA 510(k)
FDA Class 2
·General Hospital
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 4, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 17, 2011
640G INSULIN PUMP MMT-1712K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 13, 2022
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021