11 results · 27ms · Sources: EU EUDAMED, US FDA

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LARGE WOUND DRESSING KIT

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Helix

FDA UDI
Nuvasive, Inc.·00887517138965·Helix R Screw, 4x19mm Var Self-Tap

PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5

FDA 510(k)
FDA Class 2 ·Anesthesiology

BILLY BOY MALE LATEX CONDOM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

FDA Enforcement
Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

ARTICULEZE M HEAD 36MM +8.5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. REG. # 8010379·Product code JDI·May 9, 2014

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 19, 2012

TRIGEN

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JDS·August 17, 2010

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024

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

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