27 results · 23ms · Sources: EU EUDAMED, 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