18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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