13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARIES INDICATOR
FDA 510(k)
FDA Class 2
·Dental
Hern 21pc Dilator Set
FDA UDI
MEDGYN PRODUCTS, INC.·M803030807·Hern 21pc Dilator Set 44Fr (14.6 mm) - 104Fr (...
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA UDI
TENON MEDICAL, INC.·B74240308070·7.5mm Location Pin
CYSTOSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MUSCLE STIMULATOR SA-100
FDA 510(k)
FDA Class 2
·Physical Medicine
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·October 4, 2019
Y-KNOT ALL-SUTURE ANCHOR DRILL BIT
FDA Adverse Event
Malfunction
·CONMED LINVATEC·Product code GFG·April 2, 2013
AIRCAST CRYO/CUFF THERAPY UNIT
FDA Adverse Event
Injury
·DJ ORTHOPEDICS DE MEXICO·Product code ILO·March 21, 2011
NEXT MODULAR REAMER HEAD
FDA Adverse Event
Malfunction
·EBI·Product code HTO·April 17, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·October 13, 2010
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