12 results · 20ms · Sources: EU EUDAMED, US FDA

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IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198321·AK3 PS Insert Trial Size 5, 13mm

TAXOL ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE

FDA 510(k)
FDA Class 2 ·Orthopedic

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 6, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMS, INNOVATION CTR - SILICON VALLEY·Product code GEX·April 6, 2011

T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE

FDA Adverse Event
Injury ·MERCURY MEDICAL·Product code CAI·September 29, 2015

NEONATAL PATIENT CIRCUIT KIT

FDA Adverse Event
Injury ·MERCURY MEDICAL·Product code CAI·September 21, 2015

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 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

Alcon Custom Ophthalmic Surgical Procedure Packs

FDA Enforcement
Class II ·Terminated·Alcon Research, LLC·April 7, 2021