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BIOLIS 12I

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

3.5mm/2.5mm Double Drill Sleeve

FDA UDI
Osteocentric Technologies, Inc.·00816950028434·3.5mm/2.5mm Double Drill Sleeve

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317320704·

DD tempMED

FDA UDI
Dental Direkt GmbH·EDDIK110201·DD tempMED are pre-colored dental milling blank...

Block high CF ExaFix™

FDA UDI
MACROMEDICS B.V.·08719425700915·Carbon fiber elevation block, fit for ExaFix, high

Breast CT/MR Template

FDA UDI
Nucletron B.V.·08717213030985·Set of 4 template-pairs, 10 mm spacing, triple ...

SCISSORS OPER CRV S/S 6"

FDA UDI
W.H. Holden, Inc.·D9281105200·

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345027244·Inserter, 11-16MM, Lumbar Straight

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973100591·Poly Insert CR, Size 5, 20mm

GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER

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

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 14, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

SILVERHAWK® PLAQUE EXCISION SYSTEM

FDA Adverse Event
Injury ·EV3 INC.·Product code MCW·June 1, 2011

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

CAPIOX®FX

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 19, 2026

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 9, 2022

CAPIOX®FX

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 30, 2026

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 6, 2025

CAPIOX FX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 25, 2021