123 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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ZYSTON STRAIGHT SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158217898·FORCEPS STANDARD TISSUE 1X2 TEETH 5.75"
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506061158·TISSUE FORCEPS 14CM 5 1/2"
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193109183·HA PEEK EVOS Straight, ,14mmx8mmx 22mm , FLAT 5...
TALOS®-C
FDA UDI
MEDITECH SPINE, LLC·B1675112014000·
TALOS®-C
FDA UDI
MEDITECH SPINE, LLC·B1675112014070·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100140·Implant Tray, Cosmolock, Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100140·Implant Tray
TALOS®-C
FDA UDI
MEDITECH SPINE, LLC·B167511201400A0·
TALOS®-C
FDA UDI
MEDITECH SPINE, LLC·B167511201407A0·
TENS STIMULATOR, MODELS 2800 AND 3000
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ART A/PL CD/YELLOW 9
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2019
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 7, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code FPA·June 2, 2011
REVERSE SHOULDER SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·August 14, 2008
SARA 3000
FDA Adverse Event
Injury
·ARJOHUNTLEIGH POLSKA SP. Z O.O.·Product code FSA·May 20, 2021
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories, Inc.·February 19, 2014