39 results · 7ms · Sources: EU EUDAMED, US FDA

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KCI NPWT GAUZE DRESSING

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

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACIES

FDA 510(k)
FDA Class 2 ·Radiology

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MDx-Chex for BCY

FDA 510(k)
FDA Class 2 ·Microbiology

BCI 3180 PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BCI WW1030 PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BCI WW1021 PC APPLICATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACI PULSATING VACUUM PUMP SYSTEM

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

BCI 3401 HANDHELD PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYNTHES ACIS/VERTEBRAL SPACER CR

FDA 510(k)
FDA Class 2 ·Orthopedic

BCI-100 FECAL INCONTINENCE SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ACI SINGLE LUMEN BIOPSY NEEDLE

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

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)
FDA Class 2 ·Hematology

AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)

FDA 510(k)
FDA Class 2 ·Hematology

BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BCI WW1000 PULSE OXIMETER, MODEL WW1000

FDA 510(k)
FDA Class 2 ·Cardiovascular