Medical Device Manufacturer · US , Elkton , MD

Terumo Medical Corp. - FDA 510(k) Cleared Devices

143 submissions · 143 cleared · Since 1980
143
Total
143
Cleared
0
Denied
143 devices
51-75 of 143
Cleared Jun 23, 1999
CAPIOX CARDIOPLEGIA
K982467 · DTR
Cardiovascular · 343d
Cleared Jun 16, 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
K991406 · FOZ
General Hospital · 55d
Cleared Jan 27, 1999
GT LEGGIERO
K981359 · DQY
Cardiovascular · 288d
Cleared Jan 26, 1999
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
K984260 · DYB
Cardiovascular · 62d
Cleared Sep 10, 1998
CAPIOX SX HARDSHELL RESEVOIR
K982223 · DTN
Cardiovascular · 78d
Cleared May 14, 1998
CAPIOX SX HARDSHELL RESERVOIR
K980935 · DTN
Cardiovascular · 63d
Cleared Apr 02, 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · FMF
General Hospital · 72d
Cleared Jan 30, 1998
CAPIOX HEMOCONCENTRATOR
K973516 · KDI
Gastroenterology & Urology · 135d
Cleared Dec 19, 1997
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · FJI
Gastroenterology & Urology · 296d
Cleared Aug 15, 1997
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937 · OCY
Gastroenterology & Urology · 80d
Cleared Jul 07, 1997
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
K961734 · DTZ
Cardiovascular · 430d
Cleared May 06, 1997
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL...
K970463 · DTZ
Cardiovascular · 89d
Cleared Feb 25, 1997
CAPIOX SP PUMP HEAD
K962981 · KFM
Cardiovascular · 208d
Cleared Oct 16, 1996
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR
K960074 · DTZ
Cardiovascular · 279d
Cleared Oct 07, 1996
CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
K962667 · DTZ
Cardiovascular · 90d
Cleared Oct 02, 1996
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL...
K961000 · DTZ
Cardiovascular · 204d
Cleared Jul 09, 1996
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K961445 · DQX
Cardiovascular · 84d
Cleared May 21, 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · FMF
General Hospital · 274d
Cleared Feb 02, 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801 · DQX
Cardiovascular · 42d
Cleared Nov 27, 1995
RADIFOCUS INTRODUCER II KIT
K954234 · DYB
Cardiovascular · 77d
Cleared Oct 18, 1995
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K953533 · DQX
Cardiovascular · 83d
Cleared Jul 25, 1995
CAPIOX ARTERIAL FILTER
K943917 · DTM
Cardiovascular · 348d
Cleared Mar 06, 1995
CLIRANS WET PACK HOLLOW FIBER DIALYZER
K930503 · FJI
Gastroenterology & Urology · 763d
Cleared Sep 02, 1993
CAPIOX SX HOLLOW FIBER OXYGENATOR
K922799 · DTZ
Cardiovascular · 449d
Cleared Jul 13, 1993
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
K926217 · GBZ
General & Plastic Surgery · 215d

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