19 results
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20ms
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Sources: EU EUDAMED, US FDA
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEAVY TARTAR HOE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052802·HEAVY TARTAR HOE #P35 DOUBLE ENDED DOUBLE ANGLE...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973530·
SYNERGY CT PICC
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
FDA 510(k)
FDA Class 2
·Hematology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 3, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 8, 2024
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 17, 2011
ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 19, 2014
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
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
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
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015