32 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROLAB SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00311021·
IMPACT-20
FDA UDI
Denplus Inc·D8451031102·IMPACT-20, LPL, 454 g
CONTEX, INCORPORATED
FDA registration
CONTEX, INCORPORATED·4 products·🇺🇸 United States
Curette
FDA UDI
KATENA PRODUCTS, INC.·00841668102091·SHEPHERD CAPSULE POLISHER
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310020·Probe, 1.5 inch Ball, Steffee, Straight, Black
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
FDA 510(k)
FDA Class 2
·General Hospital
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 6, 2023
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 14, 2021
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 16, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 28, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 2, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 17, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·April 17, 2008
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 19, 2020
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 10, 2021
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 6, 2023
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 28, 2021
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·December 5, 2025