14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZUTRON COLONOSCOPE STIFFENING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
FDA UDI
Cynosure, LLC·00841494100360·ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
EXPLANT™
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311770·
NBS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
FDA 510(k)
FDA Class 2
·Immunology
LNOP MP12 PATIENT CABLE
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·May 15, 2015
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·April 10, 2013
XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code NKB·April 5, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·May 22, 2008
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020