23 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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