19 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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GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
FDA 510(k)
FDA Class 2
·General Hospital
GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014
GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113684·CYSTOTOME FORMED 27GA
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BACTEC MGIT 960 SIR KITS
FDA 510(k)
FDA Class 2
·Microbiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 27, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·June 30, 2025
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023
KERRISON DETACH.130DEG UP 200MM 3MM THIN
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code GXJ·May 17, 2024
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 26, 2022
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024