18 results · 23ms · Sources: EU EUDAMED, US FDA

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SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515

FDA 510(k)
FDA Class 2 ·Physical Medicine

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5820307080·SCISSORS, SURGICAL TISSUE, DENTAL

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307081·Diamond, flame, extra fine grit, yellow ring

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837050955·

APPLICATOR TIP/DUAL SPRAYER KIT

FDA 510(k)
FDA Class 2 ·General Hospital

ADVANTAGE THC/COCAINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

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

VISION HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code CBK·March 27, 2013

SOFPORT AO INTRAOCULAR LENS

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code HQL·March 18, 2011

ROTABLATOR GUIDE WIRE

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

AXIOM ICONOS R200

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE GMBH·Product code JAA·October 10, 2017

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

AXIOM ICONOS R200 C20_C

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code JAA·May 13, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

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