23 results · 38ms · Sources: EU EUDAMED, US FDA

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FIBERGRAFT BG Morsels

FDA 510(k)
FDA Class 2 ·Orthopedic

OMNI Mod Hip

FDA UDI
Omni Life Science, Inc.·00841690102663·OMNI Modular Stem Size 4, 11.5mm

Globe Scientific

FDA UDI
GLOBE SCIENTIFIC INC.·00840095620963·Pipette tip, 0.1-10uL, natural universal, bulk bag

AGC TRADITION KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304241329·

HHM

FDA UDI
Oticon A/S·05707131279781·H330, DESIGNRITE 10 WL THP HHM

POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

FDA 510(k)
FDA Class 2 ·Anesthesiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 12, 2022

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·March 31, 2016

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·March 31, 2016

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 21, 2015

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 21, 2015

TRUETRACK

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 5, 2016

SYNERGY

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 26, 2012

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·February 13, 2025

STERNALOCK BLU BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HRS·October 8, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

AUGMENTED INSERT

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011

EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

FDA Enforcement
Class II ·Terminated·Ameditech Inc·November 25, 2015

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 26, 2014