E-Z-EM, Inc
Princeton, NJ, US
E-Z-EM, INC. appears in FDA device records in Princeton, NJ. FDA records list 56 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 56FDA records hold 56 510(k) clearances for E-Z-EM, Inc between 1977 and 2007. The busiest year on record is 1991, with 8. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1984 | 5 |
| 1985 | 7 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 6 |
| 1990 | 2 |
| 1991 | 8 |
| 1992 | 8 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | JAK | Substantially Equivalent | |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | IZQ | Substantially Equivalent | |
| K063029 | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 | JAK | Substantially Equivalent | |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | FCX | Substantially Equivalent | |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | FPK | Substantially Equivalent | |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | IZQ | Substantially Equivalent | |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | FCX | Substantially Equivalent | |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | FCX | Substantially Equivalent | |
| K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | JAK | Substantially Equivalent | |
| K974621 | PERCUPUMP II WITH EDA | DSB | Substantially Equivalent | |
| K961845 | PERCUPUMP II WITH EDA | DSB | Substantially Equivalent | |
| K954926 | HM-CAP CONTROL PANEL | LYR | Substantially Equivalent | |
| K932055 | PERCUPUMP II | FIH | Substantially Equivalent | |
| K930581 | E-Z-FLATE | FCX | Substantially Equivalent | |
| K911349 | E-Z-EM ENTEROCLYSIS CATHETER SET | EZK | Substantially Equivalent | |
| K914987 | HIGH PRESSURE CONNECTING SETS, MODIFICATION | DTL | Substantially Equivalent | |
| K914986 | GUIDE WIRES, MODIFICATION | DQX | Substantially Equivalent | |
| K914984 | E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION | DQY | Substantially Equivalent | |
| K921738 | SONO-VU US(TM), MODIFICATION | HIO | Substantially Equivalent | |
| K920816 | PERCUGUIDE LESION MARKING | GDF | Substantially Equivalent | |
| K914113 | ANGIOGRAPHIC FLUSH SYSTEM | FPA | Substantially Equivalent | |
| K914026 | ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM | FPA | Substantially Equivalent | |
| K914985 | DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION | DRC | Substantially Equivalent | |
| K914330 | SOS BLOODLESS NEEDLE | DYB | Substantially Equivalent | |
| K914199 | ANGIOGRAPHIC SOFT TIP CATHETER | DQO | Substantially Equivalent | |
| K911897 | GASPARAITIS ESOPHAGRAM CATHETER SET | KNT | Substantially Equivalent | |
| K904583 | SONO-VU US(TM) | HIO | Substantially Equivalent | |
| K905409 | EIA FOR DETECTION OF ANTIBODIES H. PYLORI | LYR | Substantially Equivalent | |
| K905447 | E-Z-EM PULSED INFUSION SYSTEM | KRA | Substantially Equivalent | |
| K905574 | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | FGD | Substantially Equivalent | |
| K904299 | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | FGD | Substantially Equivalent | |
| K900021 | PERCU-SET(TM) | HIO | Substantially Equivalent | |
| K895012 | E-Z-EM VACUUM ASPIRATION SYRINGE | GAA | Substantially Equivalent | |
| K890207 | INTERVENTIONAL PRODUCTS - GUIDE WIRES | DQX | Substantially Equivalent | |
| K890209 | DISPOSABLE ANGIOGRAPHY NEEDLES | DRC | Substantially Equivalent | |
| K890208 | HIGH PRESSURE CONNECTING SETS | DXT | Substantially Equivalent | |
| K890206 | E-Z-FLOW ANGIOGRAPHY CATHETERS | DQO | Substantially Equivalent | |
| K885264 | WINGED INFUSION SET | FPA | Substantially Equivalent | |
| K882601 | E-Z-EM(R) LUFKIN BIOPSY NEEDLES | GDM | Substantially Equivalent | |
| K864227 | PERCUPUMP (TM) | FRN | Substantially Equivalent | |
| K863090 | PERCU GUIDE I (LOOP TYPE) | GDF | Substantially Equivalent | |
| K853667 | BRONCHIAL CYTOLOGY BRUSH | Substantially Equivalent | ||
| K854248 | GOODLEY POLYAXIAL CERVICAL TRACTION UNIT | Substantially Equivalent | ||
| K853666 | ENDODYNAMICS SIEGEL THERAPUTIC STENT | FGE | Substantially Equivalent | |
| K853384 | E-Z-EM GASTRIC LAVAGE CATHETER | KNT | Substantially Equivalent | |
| K853680 | ENDODYNAMIC SIEGEL SPHINCTEROTOME | KNS | Substantially Equivalent | |
| K853402 | E-Z-GUARD MOUTHPIECE | BYP | Substantially Equivalent | |
| K853530 | ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH | FDX | Substantially Equivalent | |
| K842121 | E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE | LJE | Substantially Equivalent | |
| K841720 | E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS | LJE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2411512 | 2411512 | E-Z-EM, INC. | 510 Carnegie Center, Princeton, NJ 08540 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- LJECatheter, Nephrostomy
- DQYCatheter, Percutaneous
- EZKCatheter, Retention Type
- FGDCatheter, Retention, Barium Enema With Bag
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- KYWContainer, Liquid Medication, Graduated
- FMHContainer, Specimen, Sterile
- FDXEndoscopic Cytology Brush
- GDFGuide, Needle, Surgical
- LYRHelicobacter Pylori
- DXTInjector And Syringe, Angiographic
- IZQInjector, Contrast Medium, Automatic
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- DYBIntroducer, Catheter
- JXAKit, Screening, Urine
- BYPMouthpiece, Breathing
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- DSBPlethysmograph, Impedance
- FRNPump, Infusion
- FIHPump, Infusion Or Syringe, Extra-Luminal
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- FPASet, Administration, Intravascular
- IWWShield, Vial
- FGEStents, Drains And Dilators For The Biliary Ducts
- KXZSystem, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
- KPSSystem, Tomography, Computed, Emission
- JACSystem, X-Ray, Film Marking, Radiographic
- JAKSystem, X-Ray, Tomography, Computed
- DRCTrocar
- KNTTubes, Gastrointestinal (And Accessories)
- FPKTubing, Fluid Delivery
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
- FNPUrinal
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0550-05 | Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L. | Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor. | Terminated | ||
| Z-0549-05 | Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L. | Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor. | Terminated | ||
| Z-0548-05 | Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L. | Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain