Medical Components Inc

FDA Filings

This page includes the latest FDA filings for Medical Components Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Medical Components Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2518902
FEI Number2518902
NameMEDICAL COMPONENTS INC
Owner & OperatorMedical Components Inc. (dba Medcomp)
Contact Address1499 Delp Drive
Harleysville PA 19438 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1499 DELP DRIVE
HARLEYSVILLE, PA 19438 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device



Registration Number3013750125
FEI Number3013750125
NameMedical Components, Inc.
Owner & OperatorMedical Components Inc. (dba Medcomp)
Contact Address1499 Delp Drive
Harleysville PA 19438 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3088 East 33rd Place
Yuma, AZ 85365 US
Establishment TypeRepack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Medical Components, Inc.
TRIO-CT® AC01135243MB2024-03-08
Medical Components, Inc.
TRIO-CT® AC01135153MB2024-03-08
Medical Components, Inc.
TRIO-CT® AC01135203MB2024-03-08
Medical Components, Inc.
TRIO-CT® AC01135123MB2024-03-08
Medical Components, Inc.
TRIO-CT AC011352402024-01-08
Medical Components, Inc.
TRIO-CT AC011352002024-01-08
Medical Components, Inc.
TRIO-CT AC011351502024-01-08
Medical Components, Inc.
TRIO-CT AC011351202024-01-08
Medical Components, Inc.
TRIO-CT AC011352412024-01-08
Medical Components, Inc.
TRIO-CT AC011352012024-01-08
Medical Components, Inc.
TRIO-CT AC011351512024-01-08
Medical Components, Inc.
TRIO-CT AC011351212024-01-08
Medical Components, Inc.
TRIO CT® AS01135303MB2023-11-27
Medical Components, Inc.
TRIO CT® AS01135243MB2023-11-27
Medical Components, Inc.
TRIO CT® AS01135203MB2023-11-27
Medical Components, Inc.
TRIO CT® AS01135153MB2023-11-27
Medical Components, Inc.
TRIO CT® AS01135123MB2023-11-27
Medical Components, Inc.
TRIO-CT® AS011353032023-08-24
Medical Components, Inc.
TRIO-CT® AS011352432023-08-24
Medical Components, Inc.
TRIO-CT® AS011352032023-08-24
Medical Components, Inc.
TRIO-CT® AS011351532023-08-24
Medical Components, Inc.
TRIO-CT® AS011351232023-08-24
Medical Components, Inc.
TRIO-CT® ANG011353032023-08-24
Medical Components, Inc.
TRIO-CT® ANG011352432023-08-24
Medical Components, Inc.
TRIO-CT® ANG011352032023-08-24
Medical Components, Inc.
TRIO-CT® ANG011351532023-08-24
Medical Components, Inc.
TRIO-CT® ANG011351232023-08-24
Medical Components, Inc.
Tri-Flow MCDLT3-44242023-08-10
Medical Components, Inc.
Tri-Flow MCDLT3-4400PC2023-08-10
Medical Components, Inc.
Tri-Flow MCDLT3-44002023-08-10
Medical Components, Inc.
Tri-Flow MCDLT3-4000PC2023-08-10
Medical Components, Inc.
Tri-Flow MCDLT3-40002023-08-10
Medical Components, Inc.
Tri-Flow MCDLT3-3500PC2023-08-10
Medical Components, Inc.
Tri-Flow MCDLT3-35002023-08-10
Medical Components, Inc.
Split Cath® MC20BR32023-07-05
Medical Components, Inc.
Split Cath® MC20BR22023-07-05
Medical Components, Inc.
Split Cath® MC20BR12023-07-05
Medical Components, Inc.
TRIPLE LUMEN INFUSION CATHETERS MC3L-8K2023-06-26
Medical Components, Inc.
PRO-LINE CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM) MD280351212023-05-31
Medical Components, Inc.
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) MD280351012023-05-31
Medical Components, Inc.
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) MD280361012023-05-31
Medical Components, Inc.
PRO-LINE CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM) MD280352212023-05-31
Medical Components, Inc.
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) MD280352012023-05-31
Medical Components, Inc.
PRO-LINE CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM) MD280362212023-05-31
Medical Components, Inc.
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) MD280362012023-05-31
Medical Components, Inc.
PRO-LINE CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM) MD280361212023-05-31
Medical Components, Inc.
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) MD280371012023-05-31
Medical Components, Inc.
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) MD280363012023-05-31
Medical Components, Inc.
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) MD280372012023-05-31
Medical Components, Inc.
TRIO-CT® ANG011353032023-02-16
Medical Components, Inc.
TRIO-CT® ANG011353012023-02-16
Medical Components, Inc.
TRIO-CT® ANG011353002023-02-16
Medical Components, Inc.
TRIO-CT® ANG011352432023-02-16
Medical Components, Inc.
TRIO-CT® ANG011352412023-02-16
Medical Components, Inc.
TRIO-CT® ANG011352402023-02-16
Medical Components, Inc.
TRIO-CT® ANG011352032023-02-16
Medical Components, Inc.
TRIO-CT® ANG011352012023-02-16
Medical Components, Inc.
TRIO-CT® ANG011352002023-02-16
Medical Components, Inc.
TRIO-CT® ANG011351532023-02-16
Medical Components, Inc.
TRIO-CT® ANG011351512023-02-16
Medical Components, Inc.
TRIO-CT® ANG011351502023-02-16
Medical Components, Inc.
TRIO-CT® ANG011351232023-02-16
Medical Components, Inc.
TRIO-CT® ANG011351212023-02-16
Medical Components, Inc.
TRIO-CT® ANG011351202023-02-16
Medical Components, Inc.
SYMETREX® MBNS023GL2022-08-08
Medical Components, Inc.
SYMETREX® MBNS019GL2022-08-08
Medical Components, Inc.
SYMETREX® MBPS023GL2022-08-08
Medical Components, Inc.
SYMETREX® MBPS019GL2022-08-08
Medical Components, Inc.
DUO-FLOW® XTP118MTE2022-08-08
Medical Components, Inc.
DUO-FLOW® XTP116MTE2022-08-08
Medical Components, Inc.
PERITONEAL CATHETER MPD-2632022-08-08
Medical Components, Inc.
PERITONEAL CATHETER MDC63C2022-08-08
Medical Components, Inc.
PERITONEAL CATHETER MC2001012022-08-08
Medical Components, Inc.
DUO-FLOW® 400XL DFXL149MTE2022-08-08
Medical Components, Inc.
DUO-FLOW® 400XL DFXL148MTE2022-08-08
Medical Components, Inc.
DUO-FLOW® 400XL DFXL148IJSE2022-08-08
Medical Components, Inc.
DUO-FLOW® 400XL DFXL146MTE2022-08-05
Medical Components, Inc.
SLX Hemo-Cath® MC061423MB2022-03-28
Medical Components, Inc.
SLX Hemo-Cath® MC061422MB2022-03-28
Medical Components, Inc.
SLX Hemo-Cath® MC0614032022-03-28
Medical Components, Inc.
SLX Hemo-Cath® MC0614022022-03-28
Medical Components, Inc.
BREEZE® APD BALPN1030S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0830S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0730S2022-03-07
Medical Components, Inc.
BREEZE® APD BANPN0720S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN1625S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN1225S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN1020S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0820S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN1230S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN1035S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0835S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0735S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0630S2022-03-07
Medical Components, Inc.
BREEZE® APD BANPN0620S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN1425S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN1025S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0825S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0725S2022-03-07
Medical Components, Inc.
BREEZE® APD BALPN0625S2022-03-07
Medical Components Inc. (Dba Medcomp)
Symetrex LTHD Catheter, Symetrex LTHD Catheter With Sideholes2020-09-03
Medical Components Inc. (dba MedComp)
Duo-Flow Side X Side Double Lumen Catheter2020-04-23
Medical Components Inc. (dba MedComp)
Trio-CT Triple Lumen Catheter2019-06-14
MEDICAL COMPONENTS INC [Medical Components Inc. (dba Medcomp)]
20G X 3/4" Pro-Lock Safety Infusion Set2018-08-09
Medical Components Inc. (Dba Medcomp)
12F Tri-Flow Triple Lumen Catheter2018-07-05
Medical Components, Inc. (Dba Medcomp)
15.5F X 19 Cm Symetrex Long Term Hemodialysis Catheter With Sideholes, 15.5F X 23 Cm Symetrex Long Term Hemodialysis Catheter With Sideholes, 15.5F X 28 Cm Symetrex Long Term Hemodialysis Catheter With Sideholes, 15.5F X 33 Cm Symetrex Long Term Hemo2018-05-17
Medical Components, Inc. (dba Medcomp)
C3 Wave System2018-04-12
Medical Components, Inc (Dba Medcomp_
C3 Wave System2017-12-06
Medical Components, Inc. (dba Medcomp)
CT Midline2017-07-25
MEDICAL COMPONENTS INC
PRO-PICC WITH VALVE TECHNOLOGY2014-09-29
MEDICAL COMPONENTS INC
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE2014-01-08
MEDICAL COMPONENTS INC
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET2013-08-16
MEDICAL COMPONENTS INC
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER2013-08-15
MEDICAL COMPONENTS INC
5F DIGNITY CT TITANIUM PORT2013-07-31
MEDICAL COMPONENTS INC
VALVED TEARAWAY INTRODUCER GENERATION II2013-06-03
MEDICAL COMPONENTS INC
3F PRO-PICC2013-05-15
MEDICAL COMPONENTS INC
VASU-PICC2012-12-12
MEDICAL COMPONENTS INC
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM2012-09-21
MEDICAL COMPONENTS INC
DIGNITY POWER INJECTABLE TITANIUM PORT2012-09-17
MEDICAL COMPONENTS INC
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)2012-09-05
MEDICAL COMPONENTS INC
MEDCOMP VASCU-PICC & MIDLINE CATHETERS2012-06-06
MEDICAL COMPONENTS INC
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC2012-05-02
MEDICAL COMPONENTS INC
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC2012-05-02
MEDICAL COMPONENTS INC
HEMO-CATH 10F, HEMO-CATH 12.5F2012-03-09
MEDICAL COMPONENTS INC
SPLIT CATH III2011-12-08
Medical Components, Inc. [Medical Components Inc. (dba Medcomp)]
Pro-PICC(R) CT2011-08-12
MEDICAL COMPONENTS INC [Medical Components Inc. (dba Medcomp)]
Pro-PICC(R) CT2011-08-12
MEDICAL COMPONENTS, INC.
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER2002-02-08
MEDICAL COMPONENTS, INC.
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-402001-10-03
MEDICAL COMPONENTS, INC.
MEDCOMP ASH SPLIT2001-06-21
MEDICAL COMPONENTS, INC.
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S2001-02-23
MEDICAL COMPONENTS, INC.
MEDCOMP Z-CATH2001-01-26
MEDICAL COMPONENTS, INC.
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN1999-11-10
MEDICAL COMPONENTS, INC.
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT1999-06-10
MEDICAL COMPONENTS, INC.
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH1999-06-08
MEDICAL COMPONENTS, INC.
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB1999-04-15
MEDICAL COMPONENTS, INC.
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-61999-02-26
MEDICAL COMPONENTS, INC.
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T1998-12-10
MEDICAL COMPONENTS, INC.
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M1998-05-11
MEDICAL COMPONENTS, INC.
MEDCOMP BIO-FLEX CS CATHETER (CS100)1998-02-23
MEDICAL COMPONENTS, INC.
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER1996-03-21
MEDICAL COMPONENTS, INC.
TWIN SILICONE CATHETER1995-09-25
MEDICAL COMPONENTS, INC.
MEDCOMP PERITONEAL DIALYSIS CATHETERS1994-02-02
MEDICAL COMPONENTS, INC.
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY1993-08-27
MEDICAL COMPONENTS, INC.
HEMO-CATH SILICONE ACCESS CATHETER1993-02-02
MEDICAL COMPONENTS, INC.
ACETATE CONCENTRATES FOR HEMODIALYSIS1991-03-15
MEDICAL COMPONENTS, INC.
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C1989-06-13
MEDICAL COMPONENTS, INC.
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER1989-04-17
MEDICAL COMPONENTS, INC.
MANUAL PERCUSSOR CUPS1988-12-13
MEDICAL COMPONENTS, INC.
ESOPHAGEAL STETHOSCOPE W/THERMISTOR1987-10-20
MEDICAL COMPONENTS, INC.
MEDCOMP DISPOSABLE MANIFOLD SYSTEM1986-09-29
MEDICAL COMPONENTS, INC.
MEDCOMP C.A.V.H. CATHETER1986-08-06
MEDICAL COMPONENTS, INC.
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS1986-07-02
MEDICAL COMPONENTS, INC.
MEDCOMP'S FEMORAL VEIN CATHETERS1986-04-08
MEDICAL COMPONENTS, INC.
CUP MONITORING KIT CVPK-141986-03-31
MEDICAL COMPONENTS, INC.
ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE1986-02-18
MEDICAL COMPONENTS, INC.
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-81986-02-14
MEDICAL COMPONENTS, INC.
DUO FLOW CATHETER-MC 541984-07-26
MEDICAL COMPONENTS, INC.
DOUBLE LUMEN SUBLCAVIAN-FEMORAL1984-06-25
MEDICAL COMPONENTS, INC.
TRIPLE LUMEN INFUSIONCATHETERS-1984-02-14
MEDICAL COMPONENTS, INC.
DOUBLE LUMEN INFUSION CATHETERS1984-02-10
MEDICAL COMPONENTS, INC.
MCSC6PS MEDICAL COMPONENTS1982-07-13
MEDICAL COMPONENTS, INC.
MCSCP8PS WITH 'Y' HUB1982-06-24
MEDICAL COMPONENTS, INC.
MEDCOMP SUBCLAVIAN CATHETER1980-12-18
MEDICAL COMPONENTS, INC.
HEMOCATH I KIDNEY DIALYSIS CATHETER1980-09-26
MEDICAL COMPONENTS, INC.
MEDCOMP FEMORAL VEIN CATHETER1980-09-26
MEDICAL COMPONENTS, INC.
HEMO-CATH II KIDNEY DIALYSIS CATHETER1980-09-26
MEDICAL COMPONENTS, INC.
CENTRAL VEIN CATHETERIZATION KIT1980-04-16
MEDICAL COMPONENTS, INC.
MEDICAL COMPONENTS IV CATHETER1980-04-08
MEDICAL COMPONENTS, INC.
PERCUTANEOUS INTRODUCER SET1980-03-19
MEDICAL COMPONENTS, INC.
CENTRAL VENOUS PRESSURE CATHETER1980-03-12
MEDICAL COMPONENTS, INC.
ESOPHAGEAL STETHESCOPE1980-03-10

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020082713756Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey3ML SYRINGE RED SYRINGE CAP BLUE SYRINGE CA P276 CTN
2020082617657Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey3ML SYRINGE RED SYRINGE CAP BLUE SYRINGE CA P276 CTN
2020070715184Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey3ML SYRINGE RED SYRINGECAP BLUE SYRINGE CA P276 CTN
202006081392657037 -> New York/Newark Area, Newark, New JerseySYRINGE CAP BLUE19 CTN
202005111632757037 -> New York/Newark Area, Newark, New Jersey3ML SYRINGE SYRINGE CAP RED148 CTN
2020032438330Shanghai ,China (Mainland) -> Los Angeles, California3ML SYRINGE FDA REGISTRATION NO 3005246939106 CTN
2019080818491Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey3ML SYRINGE RED SYRINGE CAP BLUE SYRINGE CAP276 CTN
201810027009Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey3ML SYRINGE RED SYRINGE CAP BLUE SYRINGE CA P276 CTN

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