9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Polyisoprene Powder Free, Black Colour Surgical Gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·May 25, 2005
SAF (SELF ADJUSTING FILE)
FDA 510(k)
FDA Class 1
·Dental
GEM-TONE BODY TRAINING SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
BMT GB KNEE STM 12X40
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 27, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 21, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016