22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743670·ACHIMED ACHILLES SUPP SILVER IV
Healqu
FDA UDI
Healqu LLC·00819143021014·Healqu Calcium Alginate Wound Dressing 4in x 4in
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717102427·Midway Select Bite Reg Regular Mint
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036019624·
B-P TOTAL SHOULDER SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024985·B-P SHOULDER GLENOID BEARING SIZE 2, 0 MM THICK...
SURE CHECK OVULATION PREDICTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VINYL EXAMINATION GLOVES STERILE POWEDERED
FDA 510(k)
FDA Class 1
·General Hospital
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Injury
·MATORHTO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
ASCEND PC
FDA Adverse Event
Other
·CALDERA MEDICAL·Product code FTL·March 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 19, 2014
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 26, 2008
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
FDA Recall
Terminated
·Lifescan Inc·Product code CGA·November 17, 2003
OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·March 22, 2007