E-Z-Em, Inc.
Medical device manufacturer in Westbury, NY.
56510(k) clearances
0PMA approvals
0recalls
Device types
- FCX Insufflator, Automatic Carbon-Dioxide For… 4
- KNT Tubes, Gastrointestinal (And Accessories) 3
- HIO Sampler, Amniotic Fluid (Amniocentesis Tray) 3
- JAK System, X-Ray, Tomography, Computed 3
- FPA Set, Administration, Intravascular 3
- IZQ Injector, Contrast Medium, Automatic 2
- LYR Helicobacter Pylori 2
- FGD Catheter, Retention, Barium Enema With Bag 2
- DQX Wire, Guide, Catheter 2
- DRC Trocar 2
- DQO Catheter, Intravascular, Diagnostic 2
- GDF Guide, Needle, Surgical 2
- DSB Plethysmograph, Impedance 2
- LJE Catheter, Nephrostomy 2
- KXZ System, Thermographic, Liquid Crystal… 2
- GDM Needle, Aspiration And Injection, Reusable 1
- FRN Pump, Infusion 1
- FPK Tubing, Fluid Delivery 1
- KNS Unit, Electrosurgical, Endoscopic (With Or… 1
- FDX Endoscopic Cytology Brush 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K071378 | Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product SeriesJAK · Special | 06/13/2007SE |
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
| K961845 | Percupump II with EdaDSB · Traditional | 01/23/1997SE |
| K954926 | Hm-Cap Control PanelLYR · Traditional | 01/30/1996SE |
| K932055 | Percupump IIFIH · Traditional | 03/21/1995SE |
| K930581 | E-Z-FlateFCX · Traditional | 07/01/1994SE |
| K911349 | E-Z-Em Enteroclysis Catheter SetEZK · Traditional | 11/16/1992SE |
| K914987 | High Pressure Connecting Sets, ModificationDTL · Traditional | 05/20/1992SE |
| K914986 | Guide Wires, ModificationDQX · Traditional | 05/20/1992SE |
| K914984 | E-Z-Flow Angiography Catheters, ModificationDQY · Traditional | 05/20/1992SE |
| K921738 | Sono-Vu Us(Tm), ModificationHIO · Traditional | 04/27/1992SE |
| K920816 | Percuguide Lesion MarkingGDF · Traditional | 04/21/1992SE |
| K914113 | Angiographic Flush SystemFPA · Traditional | 01/22/1992SE |
| K914026 | Angiodynamics Angiofill Fluid Management SystemFPA · Traditional | 01/09/1992SE |
| K914985 | Disposable Angiography Needle, ModificationDRC · Traditional | 12/20/1991SE |
| K914330 | Sos Bloodless NeedleDYB · Traditional | 12/20/1991SE |
| K914199 | Angiographic Soft Tip CatheterDQO · Traditional | 12/18/1991SE |
| K911897 | Gasparaitis Esophagram Catheter SetKNT · Traditional | 07/24/1991SE |
| K904583 | Sono-Vu Us(Tm)HIO · Traditional | 06/24/1991SE |
| K905409 | Eia for Detection of Antibodies H. PyloriLYR · Traditional | 06/10/1991SE |
| K905447 | E-Z-Em Pulsed Infusion SystemKRA · Traditional | 04/01/1991SE |
| K905574 | Slim Line Retention Tip W/ Silicone Rubber CuffFGD · Traditional | 01/24/1991SE |
| K904299 | Slim Line Retent Tip W/Silicone Inflation CuffFGD · Traditional | 11/27/1990SE |
| K900021 | Percu-Set(Tm)HIO · Traditional | 03/29/1990SE |
| K895012 | E-Z-Em Vacuum Aspiration SyringeGAA · Traditional | 12/27/1989SE |
| K890207 | Interventional Products - Guide WiresDQX · Traditional | 05/31/1989SE |
| K890209 | Disposable Angiography NeedlesDRC · Traditional | 05/19/1989SE |
| K890208 | High Pressure Connecting SetsDXT · Traditional | 05/19/1989SE |
| K890206 | E-Z-Flow Angiography CathetersDQO · Traditional | 05/19/1989SE |
| K885264 | Winged Infusion SetFPA · Traditional | 01/31/1989SE |
| K882601 | E-Z-Em(R) Lufkin Biopsy NeedlesGDM · Traditional | 07/25/1988SE |
| K864227 | Percupump (TM)FRN · Traditional | 01/16/1987SE |
| K863090 | Percu Guide I (Loop Type)GDF · Traditional | 08/29/1986SE |
| K853667 | Bronchial Cytology Brush · Traditional | 12/18/1985SE |
| K854248 | Goodley Polyaxial Cervical Traction Unit · Traditional | 11/15/1985SE |
| K853666 | Endodynamics Siegel Theraputic StentFGE · Traditional | 11/05/1985SE |
| K853384 | E-Z-Em Gastric Lavage CatheterKNT · Traditional | 11/05/1985SE |
| K853680 | Endodynamic Siegel SphincterotomeKNS · Traditional | 11/04/1985SE |
| K853402 | E-Z-Guard MouthpieceBYP · Traditional | 10/23/1985SE |
| K853530 | Endo Dynamics Gastrointestinal Cytology BrushFDX · Traditional | 10/04/1985SE |
| K842121 | E-Z-Em Single Stick Puncture/DrainageLJE · Traditional | 10/01/1984SE |
| K841720 | E-Z-Em Percutaneous Nephrostomy SetsLJE · Traditional | 07/26/1984SE |
| K841197 | Cysto-AidKNX · Traditional | 07/09/1984SE |
| K840752 | Enterocysis Tube W/Guide Wire & ConnectKNT · Traditional | 05/02/1984SE |
| K840401 | Biopsy Needles Various · Traditional | 03/12/1984SE |
| K781916 | Flext-ThermKXZ · Traditional | 02/02/1979SE |
| K781536 | Vac-U-Pac Kidney CassetteJXA · Traditional | 09/14/1978SE |
| K770986 | Flexi-Therm FilmKXZ · Traditional | 09/12/1977SE |