29 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TIANXIE
FDA 510(k)
FDA Class 2
·General Hospital
GoldSelect™
FDA UDI
ROCHESTER ELECTRO-MEDICAL, INC.·10816843020122·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496003748·NAOMI 70, SIZE S, CHAMPAGNE, GRADUATED COMPRES...
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828116541·GEN4 INTERACTIVE
OtoLase™ Starter Kit
FDA UDI
LUMENIS LTD.·07290109142807·DM DI Different from Primary DI - Yes
DM DIs:
0...
GoldSelect
FDA UDI
Advantage Medical Electronics, LLC·00849593015776·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...
GoldSelect™
FDA UDI
Advantage Medical Electronics, LLC·00849593025249·Disposable GoldSelect™ Cup Electrodes: 9MM STAM...
GoldSelect™
FDA UDI
ROCHESTER ELECTRO-MEDICAL, INC.·10816843020153·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...
GoldSelect™
FDA UDI
Advantage Medical Electronics, LLC·00849593025195·Disposable GoldSelect™ Cup Electrodes: 9MM STAM...
GoldSelect
FDA UDI
Advantage Medical Electronics, LLC·00849593015783·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...
GoldSelect™
FDA UDI
Advantage Medical Electronics, LLC·00849593015790·DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAM...
GoldSelect™
FDA UDI
Advantage Medical Electronics, LLC·00849593025164·Disposable GoldSelect™ Cup Electrodes: 9MM STAM...
MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 21, 2024
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
FDA Enforcement
Class II
·Ongoing·LUMENIS, LTD.·August 27, 2025
TOTALCARE BED
FDA Adverse Event
HILL-ROM, INC.·Product code FNL·February 12, 2013
UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSA·February 24, 2011
VISX STAR S4 IR EXCIMER LASER
FDA Adverse Event
Malfunction
·ADVANCED MEDICAL OPTICS - SANTA CLARA·Product code LZS·February 22, 2008
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
FDA Recall
Open, Classified
·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·July 22, 2025