54 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Verifine Mechanical Safety Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
TWINFIX/ULTRABRAID
FDA UDI
Smith & Nephew, Inc.·03596010539328·TWINFIX 6.5AB PRLD STR ANCHR W/NEEDLES
LUPINE ORTHOCORD
FDA UDI
Medos International Sàrl·10886705001101·LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA Absorb...
Zavation
FDA UDI
Zavation LLC·00842166132405·Ti3Z CIF 13mmx15mmx12mm -7 deg
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319707432·Freeman Rake Retractor 4" (10cm), 4 sharp prong...
ZAVATION
FDA UDI
Zavation LLC·00842166104495·CIF 13x15, 7 deg, -12
Life Instruments
FDA UDI
Life Instrument Corporation·M930721071200·Small Cobb Elevator 7 1/4" 1/2"
DRYTOUCH SUCTION STIMULATOR PROBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUPINE BR DS W/ORTHCRD
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·May 7, 2019
LUPINE BR DS W/ORTHCRD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·August 9, 2019
LUPINE BR DS W/ORTHCRD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·August 9, 2019
LUPINE BR DS W/ORTHCRD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·August 9, 2019
LUPINE BR DS W/ORTHCRD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·August 9, 2019
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·October 23, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code MAI·September 9, 2020
TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012