21 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814749·GENUMEDI EXTRA WIDE SAND SIZE VI
ScrewPlant® Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307104940·3.7mmD x 16mmL, 3.7mmD Platform
THERMOPLASTIC INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896053373·THERMOPLASTIC INSTRUMENT TRAY DEEP WITH SILICON...
SPECTRA OPTIA
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code LKN·September 18, 2023
M2A 38MM
FDA UDI
Biomet Uk Ltd·05019279053865·
DPB1 SSP UNITRAY KIT
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP.·Product code MZI·October 15, 2013
CONFORMANCE CHEMISTRY CONTROL C3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
FDA 510(k)
FDA Class 2
·Hematology
DPB1 SSP UNITRAY KIT
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP·Product code MZI·May 24, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
LAMITRODE TRIPOLE 16 SURGICAL LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2011
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 10, 2021
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
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021