JEDMED Instrument Company
Saint Louis, MO, US
JEDMED Instrument Company appears in FDA device records in Saint Louis, MO. FDA records list 93 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 93FDA records hold 93 510(k) clearances for JEDMED Instrument Company between 1979 and 2015. The busiest year on record is 1980, with 11. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 6 |
| 1980 | 11 |
| 1981 | 9 |
| 1982 | 3 |
| 1983 | 9 |
| 1984 | 6 |
| 1985 | 1 |
| 1986 | 8 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 11 |
| 1991 | 6 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 7 |
| 2003 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150248 | ORL Video NasoPharyngo-Larngoscope | EQN | Substantially Equivalent | |
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | EQN | Substantially Equivalent | |
| K021750 | LID CHAIN EYELID WEIGHTS | MML | Substantially Equivalent | |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | EQH | Substantially Equivalent | |
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | ENZ | Substantially Equivalent | |
| K953457 | JEDMED SPECTRUM ENT CABINET | ETF | Substantially Equivalent | |
| K950925 | JEDMED LARYNGEAL SCOPE | EOQ | Substantially Equivalent | |
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | KHH | Substantially Equivalent | |
| K950078 | MICROFLOW IRRIGATION SYSTEM | KMA | Substantially Equivalent | |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | EOB | Substantially Equivalent | |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | ERA | Substantially Equivalent | |
| K941356 | MICROFLOW IRRIGATION SYSTEM | GBQ | Substantially Equivalent | |
| K935247 | JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER | FEA | Substantially Equivalent | |
| K926288 | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | FSO | Substantially Equivalent | |
| K924025 | OTO-BRITE HANDLE | ERA | Substantially Equivalent | |
| K920988 | ATMOS MIRROR WARMER | LRC | Substantially Equivalent | |
| K912885 | KAPS 90 DEGREE FIBEROPTIC ADAPTOR | EQH | Substantially Equivalent | |
| K910243 | MOBILE TREATMENT CART | ETF | Substantially Equivalent | |
| K910707 | OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS | HOZ | Substantially Equivalent | |
| K910271 | VACPAC PORTABLE ASPIRATION SYSTEM | BTA | Substantially Equivalent | |
| K910357 | SOM 6V | FSO | Substantially Equivalent | |
| K904802 | VIDEO OTOSCOPE | ERA | Substantially Equivalent | |
| K902076 | J2 MICROSCOPE | FSO | Substantially Equivalent | |
| K896263 | RHINOMANOMETER | BXQ | Substantially Equivalent | |
| K896961 | HALUX EXLITE MINOR SURGERY LIGHT | GBC | Substantially Equivalent | |
| K900162 | DGH A-SAN PROBE HOLDER | HDR | Substantially Equivalent | |
| K900161 | A-SCAN ROLL-AROUND STAND | HMG | Substantially Equivalent | |
| K896298 | JEDMED S CHAIR | ETF | Substantially Equivalent | |
| K896297 | FLEXIBLE NASOPHARYNGOSCOPE | EOB | Substantially Equivalent | |
| K896274 | TYMPANOSCOPE | ERA | Substantially Equivalent | |
| K896273 | SYSTEMA ENT CABINET | ETF | Substantially Equivalent | |
| K900160 | ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER | KQM | Substantially Equivalent | |
| K896384 | FIBEROPTIC LIGHT SOURCE, FOI-1A | EQH | Substantially Equivalent | |
| K896962 | TINY HALOGEN EXAM LIGHT | KZF | Substantially Equivalent | |
| K896275 | JEDMED J-II CHAIR | FRK | Substantially Equivalent | |
| K884934 | JEDMED KP6 COLPOSCOPE | HEX | Substantially Equivalent | |
| K884933 | ENDOSTROBOSCOPE IV | EQL | Substantially Equivalent | |
| K881958 | JEDMED MAXIM ENT CABINET | ETF | Substantially Equivalent | |
| K882166 | JEDMED MICRO CCD CAMERA SYSTEM | FWD | Substantially Equivalent | |
| K863985 | EVOPORT 100 | GWJ | Substantially Equivalent | |
| K864639 | REUSABLE SURGICAL KERATOSCOPE | HLR | Substantially Equivalent | |
| K863615 | ENTHERMO IRRIGATION UNIT | ETP | Substantially Equivalent | |
| K862569 | HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) | BTA | Substantially Equivalent for Some Indications | |
| K862664 | JEDMED CCD CAMERA SYSTEM | FWD | Substantially Equivalent | |
| K862145 | JEDMED MINI-MOS VIDEO CAMERA | FWD | Substantially Equivalent | |
| K862034 | JEDMED CCD-02 VIDEO CAMERA SYSTEM | FWD | Substantially Equivalent | |
| K861298 | FISCH DRILL IRRIGATOR | KAR | Substantially Equivalent | |
| K855021 | LARYNGEAL MIRROR PRE-WARMER | ETF | Substantially Equivalent | |
| K845039 | OPERAID DISPOS. IRRIGATING KNIFE | KYG | Substantially Equivalent | |
| K841807 | OPERAID NUCLEUS | KYG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1926681 | 1926681 | JEDMED Instrument Company | 5416 JEDMED CT., Saint Louis, MO 63129 US | 2026 | and 156 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- FEAAttachment, Teaching, For Endoscope
- FNYBasin, Emesis
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)
- EOQBronchoscope (Flexible Or Rigid)
- EQJBur, Ear, Nose And Throat
- EKJBurnisher, Operative
- FWDCamera, Television, Microsurgical, Without Audio
- GBQCatheter, Continuous Irrigation
- FRKChair, Examination And Treatment
- GBBChair, Surgical, Ac-Powered
- FZKChair, Surgical, Non-Electrical
- EMMChisel, Osteotome, Surgical
- FZOChisel, Surgical, Manual
- FLGCleaner, Ultrasonic, Medical Instrument
- EMKCurette, Surgical, Dental
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- GDHGouge, Surgical, General & Plastic Surgery
- FCTHeadlight, Fiberoptic Focusing
- FXRHolder, Camera, Surgical
- FHQHolder, Needle, Gastroenterologic
- GDGHook, Surgical, General & Plastic Surgery
- GBCLamp, Surgical, Incandescent
- EQNLaryngoscope, Nasopharyngoscope
- CCWLaryngoscope, Rigid
- EQLLaryngostroboscope
- FXQLens, Camera, Surgical
- FSPLoupe, Diagnostic/Surgical
- EPTMicroscope, Surgical
- FSOMicroscope, Surgical, General & Plastic Surgery
- EAXMirror, Mouth
- EOBNasopharyngoscope (Flexible Or Rigid)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- GAANeedle, Aspiration And Injection, Disposable
- ERAOtoscope
- EKRPlugger, Root Canal, Endodontic
- BRWProtector, Dental
- EPNPump, Nebulizer, Manual
- BTAPump, Portable, Aspiration (Manual Or Powered)
- GADRetractor
- BXQRhinoanemometer (Measurement Of Nasal Decongestion)
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- EPPSplint, Nasal
- FLESterilizer, Steam
- DQDStethoscope, Electronic
- ETPStimulator, Caloric-Water
- EPWSupport, Head, Surgical, Ent
- EIBSyringe, Irrigating (Dental)
- DSPSystem, Balloon, Intra-Aortic And Control
- FTYTape, Measuring, Rulers And Calipers
- ENZTelescope, Laryngeal-Bronchial
- FSMTray, Surgical, Instrument
- BYYTube, Aspirating, Flexible, Connecting
- ETDTube, Tympanostomy
- GAZTubing, Noninvasive
- ETFUnit, Examining/Treatment, Ent
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain
