47 results · 32ms · Sources: EU EUDAMED, US FDA

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ACUPUNCTURE NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16740922400·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674092240060·

Prime

FDA UDI
C A I INDUSTRIES CORP·00807689000235·0.22x40mm acupuncture needles (10 needles with ...

RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0

FDA 510(k)
FDA Class 2 ·Radiology

MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

UNKNOWN

FDA Adverse Event
Malfunction ·COOK, INC.·Product code DTK·August 21, 2014

UNK

FDA Adverse Event
Injury ·COOK, INC.·Product code DTK·August 20, 2014

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·August 20, 2014

MARYLAND BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 3, 2013

DEVICE TWO: SECURE-C ENDPLATE ASSEMBLY, 11X12

FDA Adverse Event
Injury ·GLOBUS MEDICAL, INC.·Product code KWP·August 20, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011

GUNTHER TULIP VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·April 3, 2026

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·September 12, 2017

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·November 11, 2021

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·December 5, 2017

GUNTHER TULIP VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·November 4, 2025

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·June 4, 2019

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·May 21, 2019