14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
FDA 510(k)
FDA Class 2
·Dental
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855642·MESH 9051050 PYRAMESH IMP 10MMX50MM RND
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484473·MESH 9051050 PYRAMESH IMP 10MMX50MM RND
Pilot drill, long, Φ 2.2mm
FDA UDI
BIO CONCEPT Co., Ltd.·06947600301479·
Cortera Spinal Fixation System
FDA UDI
Xtant Medical Holdings, Inc.·00840311209842·Tap, Solid, Iliac, 10.5
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106013·BOTVIN IRIS FORCEPS 1X2 TEETH
EXPLANT™
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311688·
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
FDA 510(k)
FDA Class 2
·Anesthesiology
CALCIJECT
FDA 510(k)
FDA Class 2
·Dental
PROTECTA XT DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 10, 2013
CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·April 12, 2011
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.- REDWOOD CITY·Product code MGB·May 22, 2008
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·October 1, 2003
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012