123 results · 21ms · Sources: EU EUDAMED, 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