23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRECICE Intramedullary Limb Lengthening System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638335·CoRoent Ant TLIF PEEK, 16x10x32mm 15°
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901603252·20 BLADE FINISHING CARBIDE SAFE END SE6 - 5 PACK
OsteoMed
FDA UDI
OSTEOMED LLC·00842528102039·4.5 mm Screw Washer
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811821·Allis Forceps, 5x6 Teeth, 25.5cm
OsteoMed
FDA UDI
OSTEOMED LLC·00842528108178·4.5 mm Screw Washer, Sterile, 2 Pk
BD ACCU-FINE® PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 24, 2022
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 7, 2020
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·November 9, 2017
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 6, 2024
CLAMP SPINOUS PROCESS SHORT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·May 1, 2019
CAPSURE FIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2013
OUTLOOK ES
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·May 16, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 28, 2025
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017
FUSION COMPACT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code PGW·October 26, 2021
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019