25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310801016FFG1·NTI Diamond Fine FG
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310801016CFG1·NTI Diamond Coarse FG
LEONE SPA
FDA UDI
LEONE SPA·08033707062172·TUBE MIM 22/18 BH R
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022197·FastTrack Demo Kit, Adult, Alice 5
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022180·FastTrack Demo Kit, Pediatric, Alice 5
Electroplated diamond RA 801 016
FDA UDI
Diaswiss SA·07630049992504·Dental diamond instrument for intraoral use
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120334021·Diamond, round, very coarse grit, black ring
GE LOGIQ 700
FDA 510(k)
FDA Class 2
·Radiology
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120340251·Diamond, round, coarse grit, green ring
MAXCUT DIAMOND BURS (6/pk) CRS 6801-016
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781006801161·MAXCUT DIAMOND BURS (6/pk) Shape: Round; Size (...
MAXCUT DIAMOND BURS (6/pk) FINE 8801-016
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781008801161·MAXCUT DIAMOND BURS (6/pk) Shape: Round; Size (...
MAXCUT DIAMOND BURS (6/pk) MED 801-016
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100801161·MAXCUT DIAMOND BURS (6/pk) Shape: Round; Size (...
ELEKTA UNITY
FDA Adverse Event
Malfunction
·ELEKTA SOLUTIONS AB·Product code IYE·September 12, 2025
FLOSEAL HEMOSTATIC MATRIX
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - HAYWARD·Product code LMF·May 8, 2014
HI TORQUE CONNECT GUIDEWIRE
FDA Adverse Event
Injury
·BRIVANT, LTD.·Product code DQX·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007
Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015