13 results
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18ms
·
Sources: EU EUDAMED, US FDA
SOFT LENS FOLDER
FDA 510(k)
FDA Class 1
·Ophthalmic
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809643954·OPAQUE MATERNITY 20-30 MM HG WAIST HIGH ZIG ZAG...
NA
FDA UDI
STERILMED, INC.·10888551007399·SAW BLADE SAGITTAL K6 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007382·SAW BLADE SAGITTAL K6 K2000 SERIES
ELASTIC BANDAGE CAT.#182-186 (WIDTH)
FDA 510(k)
FDA Class 1
·General Hospital
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL
FDA 510(k)
FDA Class 2
·Immunology
VERSA-DIAL 50X21X57 HUM HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·September 22, 2021
SENSIA SR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·October 31, 2012
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 23, 2015
MD HYBRID GLENOID BASE 4MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 15, 2021
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012