27 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
FDA 510(k)
FDA Class 2
·Cardiovascular
BONE CURETTE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896082847·BONE CURETTE OVAL SIZES 1 2 3 4 FLAT HANDLE
ProCide-D Plus
FDA UDI
METREX RESEARCH, LLC·00615375005521·Sterilizing & Disinfecting Solution 28Day Glut...
TAPERLOC
FDA UDI
Biomet Orthopedics, LLC·00880304299696·
TaperLoc®
FDA UDI
Biomet Orthopedics, LLC·00887868473012·
NA
FDA UDI
STRYKER CORPORATION·07613153092735·DHS/DCS Quick Lock Attachment
NA
FDA UDI
STRYKER CORPORATION·04546540216519·3.25:1 Trinkle
FDI GLUCOSE CONTROL SOLUTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
FDA 510(k)
FDA Class 2
·Physical Medicine
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 30, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 7, 2022
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 9, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 19, 2014
PLUM XLM W/MODIFD B
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FRN·May 16, 2011
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·April 11, 2025
DELTAXSFT10 1.5MM X 1CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 22, 2021
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·April 10, 2025
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·April 10, 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
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021