12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DM-3000 DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
FDA 510(k)
FDA Class 2
·Microbiology
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
EMG TECHNOLOGY CO. LTD·Product code BTI·April 16, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 14, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·June 13, 2008
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRR·October 15, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012