20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NA
FDA UDI
Conmed Corporation·10653405005667·YANKAUER Suction Instrument without Control Ven...
NA
FDA UDI
Conmed Corporation·20653405005695·YANKAUER Suction Instrument without Control Ven...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034004·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...
PATIENT RELIEF WAX
FDA UDI
Ortho Organizers, Inc.·00190707065959·PATIENT RELIEF WAX PLAIN CLEAR-UNSCENTED
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014
0.55% ORTH-PHTHALALDEHYDE SOLUTION
FDA 510(k)
FDA Class 2
·General Hospital
XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014
TRANSDUCER, S8 3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014
TRANSDUCER S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
CADD - EXTENSION SET
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·December 18, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 3, 2013
UNKNOWN DEPUY ASR 52 CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 24, 2008
ISPAN SULFUR HEXAFLUORIDE (SF6) GAS
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPO·June 1, 2011
Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code KGZ·December 5, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024