19 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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BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
FDA 510(k)
FDA Class 2
·Microbiology
NA
FDA UDI
Medos International Sàrl·10886705003631·THREADED CLEAR CANNULA WITH OBTURATOR 8.5mm x 90mm
DePuy Mitek
FDA UDI
Provision·B504TC2141220·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114550·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 X...
CHESAPEAKE® Stabilization System
FDA UDI
VB Spine LLC·10888857082175·2-Screw Titanium Implant, Size 12x17x14 mm
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857522466·Trial Size 13x16x10 mm, 20°
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873097197·Cortex Screw 1.5mm, 22mm, Hexalobular
CANNULATED T-HANDLE HUDSON
FDA UDI
Biomet Orthopedics, LLC·00887868024368·
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
FDA 510(k)
FDA Class 2
·Orthopedic
HL168E
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
GENDRON, INC.·00842307102472·STRETCHER,CHR FRM,ENAM LTR
NA
FDA UDI
GENDRON, INC.·00842307103172·STRETCHER,CHR FRM,ENAM LTR
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 24, 2008
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 17, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 9, 2013
VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
FDA Recall
Terminated
·Plus Orthopedics USA·Product code JWH·December 2, 2005
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024