23 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MICOR CONDUCTION CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00174171·
Sonova Brand
FDA UDI
Sonova AG·07613389477054·myPhonak Junior app
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 13, 2025
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 13, 2025
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 13, 2025
SMITH & NEPHEW SUTURELOK, MODEL 7207321
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
FDA 510(k)
FDA Class 2
·General Hospital
MONOJET SYRINGE
FDA Adverse Event
Malfunction
·SHERWOOD MEDICAL CO.·Product code FMF·April 25, 1994
MONOJET SYRINGE
FDA Adverse Event
Malfunction
·SHERWOOD MEDICAL CO.·Product code FMF·April 25, 1994
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 13, 2025
NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 29, 2024
ACROBAT SUV OFF PUMP SYS, W/XP4000 STD
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·March 11, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·February 22, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·February 15, 2008
OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHD·October 8, 2014
OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1) GOWN LARGE SMS IMPERVIOUS REINFORCED (3) TOWELS ABSORBENT 15" X 20" LIF (I) PAD OBSTETRICAL X-LARGE ST. (I) PACKING VAG JNAL 4" X 36" 8PL Y XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (I) UMBILICAL CORD CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz. LIF (I) COVER SET UP 42" X 75" CLEARPOLY (1) DRAPE ABDOMINAL WITH TAPE L/F (1) BOWL WITH LID PLASTICS 80oz. L/F (1) SHEET DRAPE 41" X 58" SMS LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013