22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYBERCASES BY BAUSCH & LOMB
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780804·LEVAMED ACTIVE ANKLE SUP SLVR R II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II
Minit®
FDA UDI
ZIMMER SPINE, INC.·00889024337541·
DISTRACTION SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036090975·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00193033506523·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00195995800411·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132120·Trial, TLIF, 27L OB CRV 7Deg, 12mm
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
FDA 510(k)
FDA Class 1
·General Hospital
PRE-POWDERED NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
SCHILLER
FDA Adverse Event
Malfunction
·SCHILLER AG·Product code MHX·November 2, 2006
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·March 5, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 20, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 10, 2011
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DRS·March 12, 2008
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·November 6, 2013
2.5MM DRILL BIT/QC/GOLD/110MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HTW·August 7, 2013
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025