15 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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NEWDEAL K WIRE
FDA 510(k)
FDA Class 2
·Orthopedic
Reicodent
FDA UDI
devemed GmbH·04061644037469·Crown spreader "Esthetic"
COMFORT | SL | double...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 29, 2018
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
FDA 510(k)
FDA Unclassified
·Unknown
MTP CLEARVISION DISPOSABLE TUBING SET
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·March 15, 2019
STERLING?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·March 27, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 17, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·April 1, 2008
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·February 4, 2019
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2018
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2019
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018