9 results · 28ms · Sources: EU EUDAMED, US FDA

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CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

XTRAC EXCIMER LASER SYSTEM, MODEL AL7000

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223

FDA 510(k)
FDA Class 2 ·Anesthesiology

STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

FDA Enforcement
Class III ·Terminated·Advanced Sterilization Products·December 11, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 2, 2013

SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

FDA Adverse Event
Injury ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·March 18, 2011

AMPLATZ SUPER STIFF GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code DQX·April 15, 2008

Easy Go Vac Aspirator, Model PM65. Portable suction unit

FDA Recall
Terminated ·Precision Medical, Inc.·Product code BTA·November 9, 2004

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