22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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US SA Implant System
FDA 510(k)
FDA Class 2
·Dental
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00860006434519·Tasso+ allows self-collection of a capillary bl...
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479205376·Exam Shorts NON-WOVEN | BLUE x-Large (25/bg, ...
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916157234·ZEUS®-L CUP CURETTE, BAYONET, UP BITING 3MM
Sentry
FDA UDI
Life Spine, Inc.·00190837034207·T25 SCREWDRIVER
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018
POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HAEMONETICS 40U RBC FILTER BAG
FDA 510(k)
FDA Class 2
·General Hospital
EASYSPINE SCREW, UNKOWN SIZE OR TYPE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·August 17, 2020
MERIT HEMOSTASIS VALVE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQX·August 25, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 13, 2011
9611369-2008-00558
FDA Adverse Event
Malfunction
·Product code KDI·July 11, 2008
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code NKB·March 24, 2020
EASYSPINE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code NKB·July 9, 2019