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
26-50 of 143
Cleared Sep 06, 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · DYB
Cardiovascular · 26d
Cleared Aug 16, 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · FMF
General Hospital · 19d
Cleared Aug 04, 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · DYB
Cardiovascular · 49d
Cleared Mar 23, 2004
TERUMO SURGUARD2 SAFETY NEEDLE
K040531 · FMI
General Hospital · 22d
Cleared Mar 11, 2004
PROGREAT
K033913 · KRA
Cardiovascular · 85d
Cleared Dec 12, 2003
PROGREAT
K033583 · DQO
Cardiovascular · 29d
Cleared Jul 08, 2003
TERUMO SURGUARD 2 SAFETY NEEDLE
K031453 · FMI
General Hospital · 62d
Cleared Feb 21, 2003
TERUMO SURGUARD SAFETY SYRINGE
K024249 · MEG
General Hospital · 60d
Cleared Dec 18, 2002
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271 · FMF
General Hospital · 78d
Cleared Nov 21, 2001
RENAL GUIDING SHEATH
K012854 · DYB
Cardiovascular · 89d
Cleared Nov 20, 2001
CLIRANS E-SERIES DIALYZER
K013550 · KDI
Gastroenterology & Urology · 27d
Cleared Nov 14, 2001
CAROTID GUIDING SHEATH
K012812 · DYB
Cardiovascular · 84d
Cleared Oct 15, 2001
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · FPA
General Hospital · 24d
Cleared Aug 27, 2001
TERUMO 30 GAUGE HYPODERMIC NEEDLE
K012646 · FMI
General Hospital · 14d
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103 · FPA
General Hospital · 62d
Cleared Feb 12, 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · FMF
General Hospital · 84d
Cleared Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · KDI
Gastroenterology & Urology · 90d
Cleared Nov 21, 2000
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · DYB
Cardiovascular · 18d
Cleared Sep 06, 2000
CAPIOX ARTERIAL FILTER
K002026 · DTM
Cardiovascular · 65d
Cleared Jun 09, 2000
TERUMO U-100 INSULIN SYRING
K001474 · FMF
General Hospital · 29d
Cleared Jun 05, 2000
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT...
K993772 · DTZ
Cardiovascular · 210d
Cleared Mar 02, 2000
TERUMO NEEDLE WITH LOCKING SHEATH
K000387 · FMI
General Hospital · 24d
Cleared Sep 09, 1999
TERUMO U-100 INSULIN SYRINGE
K992802 · FMF
General Hospital · 21d
Cleared Sep 03, 1999
CAPIOX SX10 HARDSHELL RESEVOIR
K991973 · DTN
Cardiovascular · 84d
Cleared Aug 10, 1999
RADIFOCUS OPTITORQUE
K992051 · DQO
Cardiovascular · 53d

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