Richards Medical Co., Inc.
Walker, MI, US
Richards Medical Co., Inc. appears in FDA device records in Walker, MI. FDA records list 71 510(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
- 71
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 71FDA records hold 71 510(k) clearances for Richards Medical Co., Inc. between 1983 and 1990. The busiest year on record is 1987, with 15. The most recent is 1990, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 11 |
| 1985 | 9 |
| 1986 | 9 |
| 1987 | 15 |
| 1988 | 13 |
| 1989 | 8 |
| 1990 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS | KWP | Substantially Equivalent for Some Indications | |
| K900628 | MODULAR HIP SYSTEM | LZO | Substantially Equivalent for Some Indications | |
| K896580 | UNI-POLAR HEAD | LZY | Substantially Equivalent | |
| K895241 | INTRAMEDULLARY HIP SCREW | KTT | Substantially Equivalent | |
| K884824 | TRICON-M TOTAL KNEE SYSTEM | MBV | Substantially Equivalent for Some Indications | |
| K896204 | ZIRCONIA CERAMIC HEAD ADD'L SIZES | LZO | Substantially Equivalent for Some Indications | |
| K895242 | PAPPAS TRI-FLANGE VENTILATION TUBE | ETD | Substantially Equivalent | |
| K893377 | RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS | HSB | Substantially Equivalent | |
| K885069 | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) | LZO | Substantially Equivalent for Some Indications | |
| K892366 | POROUS GENESIS STEMMED TIBIAL COMPONENT | JWH | Substantially Equivalent for Some Indications | |
| K890132 | POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. | JWH | Substantially Equivalent for Some Indications | |
| K885036 | POROUS COATED GENESIS FEMORAL COMPONENT | JWH | Substantially Equivalent for Some Indications | |
| K884263 | ROGOZINSKI SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K884457 | MODULAR COLLARED HJD TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K882244 | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | EPP | Substantially Equivalent | |
| K881769 | HJD CALCAR REPLACEMENT PROSTHESIS | JDI | Substantially Equivalent | |
| K881143 | IMPULSE TVC (RICHARDS, OMNI, MARCON) | ESD | Substantially Equivalent | |
| K881117 | RESUBMITTING OF HJD TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K880284 | ADDVANTAGE:TVC MARCON | ESD | Substantially Equivalent | |
| K880286 | OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP | ESD | Substantially Equivalent | |
| K880285 | RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP | ESD | Substantially Equivalent | |
| K874619 | SPECTRON EF ACETABULAR COMPONENT | JDI | Substantially Equivalent | |
| K874868 | OPTI-FIX COLLARED FEMORAL COMPONENTS | JDG | Substantially Equivalent for Some Indications | |
| K875156 | STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM | JDQ | Substantially Equivalent | |
| K874215 | ENDOSCOPES FOR SINUS SURGERY | EOB | Substantially Equivalent | |
| K874707 | POST AURICULAR HEARING AID 46PP-PC SUMMIT | ESD | Substantially Equivalent | |
| K873300 | SERVICE MASTER (IMPULSE) | LRB | Substantially Equivalent | |
| K872645 | AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR | LRB | Substantially Equivalent | |
| K873797 | TI-FIT TOTAL HIP SYSTEM | LWJ | Substantially Equivalent | |
| K873559 | U-IMPULSE TVC AIR CONDUCTION HEARING AID | ESD | Substantially Equivalent | |
| K873560 | U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID | ESD | Substantially Equivalent | |
| K871146 | GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) | JWH | Substantially Equivalent | |
| K870128 | HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) | JDI | Substantially Equivalent for Some Indications | |
| K871608 | RODRIGUEZ NAIL | HSB | Substantially Equivalent | |
| K870877 | BIO-VENT REUTER BOBBIN TUBE | ETD | Substantially Equivalent | |
| K864857 | OPTI-FIX ACETABULAR COMPONENT | JDI | Substantially Equivalent for Some Indications | |
| K870961 | RICHARDS EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K870129 | VENTILATION TUBES WITH HYDROGEL COATING | ETD | Substantially Equivalent | |
| K864444 | SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE | ETA | Substantially Equivalent | |
| K864443 | EGG-TOP TORP AND EGG-TOP PORP | ETA | Substantially Equivalent | |
| K863237 | HYDROXYLAPATITE BONE GRAFT MATERIAL | LYC | Substantially Equivalent | |
| K863360 | NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE | GEI | Substantially Equivalent | |
| K862314 | HIP CONTINUOUS PASSIVE MOTION MACHINE | BXB | Substantially Equivalent | |
| K861369 | INCUS/STAPES PROSTHESIS | ETB | Substantially Equivalent | |
| K862225 | INTERNATIONAL TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K860275 | TI-FIT ACETABULAR COMPONENT | LZO | Substantially Equivalent | |
| K855183 | COFIELD SHOULDER SYSTEM | KWS | Substantially Equivalent | |
| K860635 | OPTI-FIX TOTAL HIP SYSTEM | LPH | Substantially Equivalent for Some Indications | |
| K854791 | BIO-FIT HIP SYSTEM | KWL | Substantially Equivalent | |
| K854325 | TRICON UNICOMPARTMENTAL KNEE SYSTEM | HSX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- HRXArthroscope
- LYCBone Grafting Material, Synthetic
- JDQCerclage, Fixation
- JECComponent, Traction, Invasive
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- BXBExerciser, Powered
- LRBFace Plate Hearing Aid
- ESDHearing Aid, Air-Conduction, Prescription
- GEYMotor, Surgical Instrument, Ac-Powered
- EOBNasopharyngoscope (Flexible Or Rigid)
- FZDProsthesis, Ear, Internal
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- EWLProsthesis, Laryngeal (Taub)
- ETBProsthesis, Partial Ossicular Replacement
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- ETAReplacement, Ossicular Prosthesis, Total
- HSBRod, Fixation, Intramedullary And Accessories
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- EPPSplint, Nasal
- IPFStimulator, Muscle, Powered
- KCYTourniquet, Pneumatic
- ETDTube, Tympanostomy
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
