92 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CTXA Hip Extended Reference Data
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...
CTXA HIP EXTENDED REFERENCE DATA
FDA 510(k)
FDA Class 2
·Radiology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950008766·ELECTRODE CLOTH ROUND 2" DIA 3/STRIP 10STRIPS/BAG
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120303301·Diamond, cylinder rounded edge, medium grit
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175085·Z-Rod, Dia. 5.5mm, Titanium, 330mm
Holder, Needle, Micro, Streamline/catch round-handle heavy 30cm tip 2.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034006979·Holder, Needle, Micro, Streamline/catch
round-...
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)
FDA 510(k)
FDA Class 2
·Radiology
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
Arthrex®
FDA UDI
ARTHREX, INC.·00888867427822·Probe, Articulating, 3.0 x 330mm
Arthrex®
FDA UDI
ARTHREX, INC.·00888867427686·Cup Forceps, 3.0 x 330mm
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862158116·
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862156716·TRIAL, CR FEMORAL, LOGIC®, RIGHT, SIZE 3
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 2, 2013
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·March 21, 2011
PD CYCLER 110 VOLT HOME CHOICE PRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 16, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 22, 2023
LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code JWH·March 19, 2024
LOGIC CR TIB INSERT STD, SZ 3, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024