Downs Surgical, Ltd.
Mchenry, IL, US
Downs Surgical , Ltd. appears in FDA device records in Mchenry, IL. FDA records list 60 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 60
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 60FDA records hold 60 510(k) clearances for Downs Surgical, Ltd. between 1980 and 1990. The busiest year on record is 1990, with 13. The most recent is 1990, with 13.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 5 |
| 1982 | 5 |
| 1984 | 11 |
| 1985 | 4 |
| 1986 | 9 |
| 1987 | 7 |
| 1988 | 4 |
| 1990 | 13 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | GDM | Substantially Equivalent | |
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | GDM | Substantially Equivalent | |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | GDM | Substantially Equivalent | |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | GDM | Substantially Equivalent | |
| K900616 | SHEPPERD CUTTING FORCEPS | HRX | Substantially Equivalent | |
| K900615 | SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE | HRX | Substantially Equivalent | |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | HRX | Substantially Equivalent | |
| K900613 | SHEPPERD SHELTER TUBE COMPLETE & DRILL | HRX | Substantially Equivalent | |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | HRX | Substantially Equivalent | |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | HRX | Substantially Equivalent | |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | HRX | Substantially Equivalent | |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | HRX | Substantially Equivalent | |
| K900608 | SHEPPERD LUMBAR DISCECTOMY SYSTEM | HRX | Substantially Equivalent | |
| K881757 | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS | ETN | Substantially Equivalent | |
| K881912 | SANO CLIP APPLIERS & REMOVERS | HCI | Substantially Equivalent | |
| K881911 | NEW SIZES SUGITA CLIPS | HCI | Substantially Equivalent | |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | HAO | Substantially Equivalent | |
| K874630 | RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS | HAO | Substantially Equivalent | |
| K873934 | RANGE OF CROCODILE ACTION INSTRUMENTS | GZX | Substantially Equivalent | |
| K873933 | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM | GZX | Substantially Equivalent | |
| K871947 | MODIFIED HUCKSTEP INTRAMEDULLARY NAIL | HSB | Substantially Equivalent | |
| K871956 | MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT | KWA | Substantially Equivalent | |
| K870887 | WARD'S BREAST MEASURING DEVICE | Substantially Equivalent | ||
| K864515 | RING UPM TOTAL HIP REPLACEMENT | KWA | Substantially Equivalent | |
| K864631 | MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE. | Substantially Equivalent | ||
| K863119 | CANNULATED LAG SCREWS | HTY | Substantially Equivalent | |
| K862945 | DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES | Substantially Equivalent | ||
| K861629 | KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES | HAW | Substantially Equivalent | |
| K862696 | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP | HBT | Substantially Equivalent | |
| K862331 | FUJITSU MALLEABLE - TIP BRAIN SPATULA | HAO | Substantially Equivalent | |
| K861630 | NEUROSURGICAL INSTURMENTS (VARIOUS) | HAO | Substantially Equivalent | |
| K854711 | FIBRELIGHT ILLUMINATING ORAL RETRACTORS | EIG | Substantially Equivalent | |
| K853708 | LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE | KAE | Substantially Equivalent | |
| K853589 | SHAH SELF-CLEARING MASTOID SUCTION TUBE | JZF | Substantially Equivalent | |
| K853588 | FIBRELIGHT NASAL SPECULA | EPY | Substantially Equivalent | |
| K853709 | A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM | HRS | Substantially Equivalent | |
| K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | HDF | Substantially Equivalent | |
| K840547 | WILCOX ROD & PLATE BENDER | Substantially Equivalent | ||
| K843371 | VALVOTOMY KNIFE | EMF | Substantially Equivalent | |
| K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | HDF | Substantially Equivalent | |
| K843100 | INSTRUMENTS FOR MICRO ANASTOMOSIS | GAD | Substantially Equivalent | |
| K842700 | BASILDON-GARDNER SPINAL FRAME | FWZ | Substantially Equivalent | |
| K842698 | BRITISH SPINAL FUSION SET | FZX | Substantially Equivalent | |
| K842697 | ROOTMAN ORBITAL SURGERY INSTRUMENT SET | HNR | Substantially Equivalent | |
| K842702 | ROSENBERG SKIN GRAFTING KNIVES | GFD | Substantially Equivalent | |
| K842701 | HOPPENSTEIN MICROSURGICAL SPINAL INSTRU | FZS | Substantially Equivalent | |
| K842699 | ISLAM BONE MARROW ASPIRATION NEEDLES | GAA | Substantially Equivalent | |
| K841125 | HUCKSTEPS STAPLES | Substantially Equivalent | ||
| K821772 | SURGITA/MIZHO MICRONEUROSURGERY HEAD FR | HBL | Substantially Equivalent | |
| K821358 | MODIFIED RONGEURS FOR SPINAL & ORTH. S. | EMH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HCIApplier, Aneurysm Clip
- HBTApplier, Hemostatic Clip
- HRXArthroscope
- JECComponent, Traction, Invasive
- FZSCurette, Surgical, General Use
- GFDDermatome
- KAEForceps, Ent
- HNRForceps, Ophthalmic
- EMHForceps, Rongeur, Surgical
- FZXGuide, Surgical, Instrument
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- IWYHolder, Head, Radiographic
- GZXInstrument, Microsurgical
- HAOInstrument, Surgical, Non-Powered
- EMFKnife, Surgical
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- HAWNeurological Stereotaxic Instrument
- FWZOperating Room Accessories Table Tray
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- GADRetractor
- EIGRetractor, All Types
- HSBRod, Fixation, Intramedullary And Accessories
- EPYSpeculum, Ent
- HDFSpeculum, Vaginal, Metal
- ETNStimulator, Nerve
- IYBTube Mount, X-Ray, Diagnostic
- JZFTube, Ear Suction
- LHFWarmer, Microwave, Infusion Fluid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Downs Surgical, Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Downs Surgical, Ltd.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain