12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113394·MICS TRAP KNIFE 1.8/2.2 (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
FDA 510(k)
FDA Class 2
·Cardiovascular
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 4, 2019
12/14 ARTICUL 40MM M SPEC+12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 27, 2014
EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KDJ·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 14, 2026
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