Company ยท US
Manan Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2005. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNW | Instrument, Biopsy | 10 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 4 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 |
| GAA | Needle, Aspiration And Injection, Disposable | 3 |
| LJE | Catheter, Nephrostomy | 3 |
| EXF | Bag, Bile Collecting | 2 |
| IWJ | System, Applicator, Radionuclide, Manual | 2 |
| KXK | Source, Brachytherapy, Radionuclide | 2 |
| DQY | Catheter, Percutaneous | 1 |
| DWO | Needle, Biopsy, Cardiovascular | 1 |
| FCG | Biopsy Needle | 1 |
| FEW | Catheter, Malecot | 1 |
| FMF | Syringe, Piston | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FRG | Wrap, Sterilization | 1 |
| GDF | Guide, Needle, Surgical | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 1, 2005 | K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE Manan Medical Products, Inc. | KNW |
| Jun 26, 2001 | K011209 | MANAN SPRITACRE SPINAL NEEDLES Manan Medical Products, Inc. | BSP |
| Jan 8, 1999 | K983620 | MANAN SPINAL NEEDLES Manan Medical Products, Inc. | BSP |
| Jul 31, 1998 | K980536 | EPIDURAL NEEDLE Manan Medical Products, Inc. | BSP |
| Jun 29, 1998 | K981386 | MANAN BLUNT NEEDLE Manan Medical Products, Inc. | FPA |
| Feb 6, 1998 | K980211 | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES Manan Medical Products, Inc. | KNW |
| Jan 8, 1998 | K974446 | MANAN AUTOMATIC CUTTING NEEDLE Manan Medical Products, Inc. | KNW |
| Oct 9, 1997 | K962977 | MRI COMPATIBLE BIOPSY NEEDLES Manan Medical Products, Inc. | KNW |
| May 16, 1997 | K963767 | MANAN V.S. ACCESS NEEDLE/SET Manan Medical Products, Inc. | FGE |
| Mar 13, 1997 | K961986 | MANAN D BAG Manan Medical Products, Inc. | EXF |
| Jan 10, 1997 | K962001 | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE Manan Medical Products, Inc. | FMI |
| Dec 13, 1996 | K963849 | MANAN D BAG Manan Medical Products, Inc. | EXF |
| Dec 6, 1996 | K963743 | MANAN PROSTATE UNI-LOCK Manan Medical Products, Inc. | IWJ |
| Jul 3, 1996 | K961377 | MANAN PROSTATE LOCKING INTRODUCER SET Manan Medical Products, Inc. | IWJ |
| May 23, 1996 | K961216 | MANAN INTRODUCER SHEALTH/NEEDLE Manan Medical Products, Inc. | FGE |
| Mar 26, 1996 | K954147 | MANAN MALECOT BASKET DRAINAGE CATHETER Manan Medical Products, Inc. | FEW |
| Mar 26, 1996 | K954132 | MANAN MANTA CATHETER FIXATION DISK Manan Medical Products, Inc. | KNY |
| Mar 26, 1996 | K954043 | MANAN BILIARY DRAINAGE CATHETER Manan Medical Products, Inc. | FGE |
| Mar 26, 1996 | K953713 | MANAN GENERAL UTILITY DRAINAGE CATHETER Manan Medical Products, Inc. | LJE |
| Mar 26, 1996 | K953601 | MANAN UNIVERSAL SUMP DRAINAGE CATHETER Manan Medical Products, Inc. | LJE |
| Aug 30, 1995 | K953547 | MANAN NEPHROSTOMY DRAINAGE CATHETER Manan Medical Products, Inc. | LJE |
| Mar 22, 1995 | K943649 | GERTIE MARX NEEDLE Manan Medical Products, Inc. | BSP |
| Mar 2, 1995 | K950732 | MANAN SUPER-CORE BIOPSY NEEDLE Manan Medical Products, Inc. | KNW |
| Jan 30, 1995 | K943653 | MAMMOCORE BIOPSY TRAY Manan Medical Products, Inc. | FRG |
| Sep 29, 1994 | K943651 | TECHNA-CUT ASPIRATION NEEDLE Manan Medical Products, Inc. | KNW |
| Aug 26, 1994 | K943650 | LIVER BIOPSY KIT Manan Medical Products, Inc. | KNW |
| Feb 25, 1994 | K940365 | MANAN ADAPTER FOR BARD BIOPTY SYSTEM Manan Medical Products, Inc. | KNW |
| Feb 25, 1994 | K940025 | MANAN BONE MARROW HARVEST NEEDLES Manan Medical Products, Inc. | GAA |
| Feb 25, 1994 | K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE Manan Medical Products, Inc. | GAA |
| Nov 12, 1993 | K933448 | MANAN ADAPTER FOR BIP BIOPSY DEVICE Manan Medical Products, Inc. | KNW |
| May 14, 1992 | K914941 | SIMON BREAST LESION LOCALIZATION NEEDLE Manan Medical Products, Inc. | GDF |
| Feb 18, 1992 | K914874 | MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE Manan Medical Products, Inc. | KNW |
| Aug 28, 1991 | K912074 | BONE MARROW BIOPSY TRAY Manan Medical Products, Inc. | GAA |
| Sep 5, 1990 | K902177 | MANAN BONE BIOPSY NEEDLE Manan Medical Products, Inc. | GDM |
| Aug 23, 1990 | K900978 | MANAN ARTERIAL CATHETER NEEDLE Manan Medical Products, Inc. | DQY |
| Aug 10, 1990 | K902622 | MANAN PROSTATE SEEDING NEEDLE Manan Medical Products, Inc. | KXK |
| Oct 18, 1989 | K895897 | MANAN PROSTATIC BIOPSY NEEDLE Manan Medical Products, Inc. | FCG |
| Apr 11, 1989 | K890925 | MANAN BONE MARROW BIOPSY NEEDLE Manan Medical Products, Inc. | DWO |
| Sep 28, 1988 | K883744 | MANAN HUBER STYLE INFUSION NEEDLE Manan Medical Products, Inc. | FMF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2005 | Manan Medical Products, Inc. Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, Terminated |
KXK | K902622 |