16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Eagle Heavy Duty Latex Examination Gloves
FDA UDI
Eagle Protect Pbc·09421024254889·Heavy Duty Latex Examination Gloves, Blue, Powd...
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975052728·
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158219564·SUCTION TUBE ROSEN 1.2MMØ LUER-LOCK 4"
LEONE SPA
FDA UDI
LEONE SPA·08033707010609·CALIBRA 1ST MOLAR BANDS n.UL 12
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180517758·PLIF/TLIF Shaver w/T-Handle, 12mm
STILLE Osteotomes
FDA UDI
Stille AB·07332339206321·OSTEOTOME ORIGINAL STILLE delicate 12 mm 21 cm ...
INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025
NOBELPROCERA IPS E.MAX CROWN
FDA 510(k)
FDA Class 2
·Dental
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
12.6CM TAPERED ATTACHMENT, BLACK MAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·May 24, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 30, 2014
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·June 14, 2011
INSERT 90-SRK-130512 PS SIZE 5 X 12MM (KNEE)
FDA Adverse Event
Injury
·MEDTRONIC ADVANCED ENERGY, LLC·Product code JWH·April 22, 2019
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 19, 2013
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024