154 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAL System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEGA5.5 SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809228125784·Rod, Ø5.5 x 240mm
Thino Roth Bracket, .022 Mini, UR4, w/o hook
FDA UDI
Astar Orthodontics Inc.·06941673501576·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...
TI-MAX X450
FDA 510(k)
FDA Class 1
·Dental
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985381·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985374·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985350·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985312·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985398·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985329·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985404·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985367·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985305·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985336·MIC-KEY* Gastrostomy Feeding Tube
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770985343·MIC-KEY* Gastrostomy Feeding Tube
Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Arjo Inc., Roselle, IL 60172; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610. The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff.
FDA Recall
Terminated
·ArjoHuntleigh·Product code FSA·April 27, 2009
UNK
FDA Adverse Event
Injury
·UNK·Product code FTL·October 24, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011