Company ยท US
Downs Surgical , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1990. Name variants (Inc, Corp, punctuation) are merged.
60510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 10 |
| GDM | Needle, Aspiration And Injection, Reusable | 5 |
| HAO | Instrument, Surgical, Non-Powered | 5 |
| GZX | Instrument, Microsurgical | 2 |
| HCI | Applier, Aneurysm Clip | 2 |
| HDF | Speculum, Vaginal, Metal | 2 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 |
| EIG | Retractor, All Types | 1 |
| EMF | Knife, Surgical | 1 |
| EMH | Forceps, Rongeur, Surgical | 1 |
| EPY | Speculum, Ent | 1 |
| ETN | Stimulator, Nerve | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 |
| FZS | Curette, Surgical, General Use | 1 |
| FZX | Guide, Surgical, Instrument | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| GAD | Retractor | 1 |
| GFD | Dermatome | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 1990 | K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E Downs Surgical , Ltd., GB | GDM |
| Oct 31, 1990 | K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U Downs Surgical , Ltd., GB | GDM |
| Oct 31, 1990 | K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V Downs Surgical , Ltd., GB | GDM |
| Oct 31, 1990 | K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U Downs Surgical , Ltd., GB | GDM |
| Oct 22, 1990 | K900616 | SHEPPERD CUTTING FORCEPS Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900615 | SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900613 | SHEPPERD SHELTER TUBE COMPLETE & DRILL Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES Downs Surgical , Ltd., GB | HRX |
| Oct 22, 1990 | K900608 | SHEPPERD LUMBAR DISCECTOMY SYSTEM Downs Surgical , Ltd., GB | HRX |
| Jul 15, 1988 | K881757 | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS Downs Surgical , Ltd. | ETN |
| Jun 6, 1988 | K881912 | SANO CLIP APPLIERS & REMOVERS Downs Surgical , Ltd. | HCI |
| Jun 6, 1988 | K881911 | NEW SIZES SUGITA CLIPS Downs Surgical , Ltd. | HCI |
| Feb 11, 1988 | K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE Downs Surgical , Ltd., GB | HAO |
| Dec 23, 1987 | K874630 | RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS Downs Surgical , Ltd. | HAO |
| Dec 17, 1987 | K873934 | RANGE OF CROCODILE ACTION INSTRUMENTS Downs Surgical , Ltd., GB | GZX |
| Dec 17, 1987 | K873933 | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM Downs Surgical , Ltd. | GZX |
| Aug 5, 1987 | K871947 | MODIFIED HUCKSTEP INTRAMEDULLARY NAIL Downs Surgical , Ltd., GB | HSB |
| Jun 23, 1987 | K871956 | MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT Downs Surgical , Ltd., GB | KWA |
| Mar 31, 1987 | K870887 | WARD'S BREAST MEASURING DEVICE Downs Surgical , Ltd., GB | |
| Mar 13, 1987 | K864515 | RING UPM TOTAL HIP REPLACEMENT Downs Surgical , Ltd., GB | KWA |
| Dec 18, 1986 | K864631 | MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE. Downs Surgical , Ltd., GB | |
| Sep 3, 1986 | K863119 | CANNULATED LAG SCREWS Downs Surgical , Ltd., GB | HTY |
| Aug 20, 1986 | K862945 | DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES Downs Surgical , Ltd. | |
| Aug 12, 1986 | K861629 | KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES Downs Surgical , Ltd. | HAW |
| Jul 30, 1986 | K862696 | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP Downs Surgical , Ltd. | HBT |
| Jul 1, 1986 | K862331 | FUJITSU MALLEABLE - TIP BRAIN SPATULA Downs Surgical , Ltd. | HAO |
| May 9, 1986 | K861630 | NEUROSURGICAL INSTURMENTS (VARIOUS) Downs Surgical , Ltd. | HAO |
| Feb 25, 1986 | K854711 | FIBRELIGHT ILLUMINATING ORAL RETRACTORS Downs Surgical , Ltd. | EIG |
| Feb 14, 1986 | K853708 | LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE Downs Surgical , Ltd. | KAE |
| Dec 23, 1985 | K853589 | SHAH SELF-CLEARING MASTOID SUCTION TUBE Downs Surgical , Ltd. | JZF |
| Dec 18, 1985 | K853588 | FIBRELIGHT NASAL SPECULA Downs Surgical , Ltd. | EPY |
| Nov 15, 1985 | K853709 | A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM Downs Surgical , Ltd. | HRS |
| Oct 29, 1985 | K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL Downs Surgical , Ltd., GB | HDF |
| Oct 31, 1984 | K840547 | WILCOX ROD & PLATE BENDER Downs Surgical , Ltd. | |
| Oct 25, 1984 | K843371 | VALVOTOMY KNIFE Downs Surgical , Ltd. | EMF |
| Oct 1, 1984 | K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN Downs Surgical , Ltd. | HDF |
| Sep 27, 1984 | K843100 | INSTRUMENTS FOR MICRO ANASTOMOSIS Downs Surgical , Ltd. | GAD |
| Sep 12, 1984 | K842700 | BASILDON-GARDNER SPINAL FRAME Downs Surgical , Ltd. | FWZ |
| Sep 12, 1984 | K842698 | BRITISH SPINAL FUSION SET Downs Surgical , Ltd. | FZX |
| Aug 7, 1984 | K842697 | ROOTMAN ORBITAL SURGERY INSTRUMENT SET Downs Surgical , Ltd. | HNR |
| Aug 2, 1984 | K842702 | ROSENBERG SKIN GRAFTING KNIVES Downs Surgical , Ltd. | GFD |
| Aug 2, 1984 | K842701 | HOPPENSTEIN MICROSURGICAL SPINAL INSTRU Downs Surgical , Ltd. | FZS |
| Aug 2, 1984 | K842699 | ISLAM BONE MARROW ASPIRATION NEEDLES Downs Surgical , Ltd. | GAA |
| May 23, 1984 | K841125 | HUCKSTEPS STAPLES Downs Surgical , Ltd. | |
| Sep 28, 1982 | K821772 | SURGITA/MIZHO MICRONEUROSURGERY HEAD FR Downs Surgical , Ltd. | HBL |
| May 28, 1982 | K821358 | MODIFIED RONGEURS FOR SPINAL & ORTH. S. Downs Surgical , Ltd. | EMH |
Newest 50 of 60.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||