19 results · 28ms · Sources: EU EUDAMED, 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