Medical Device Manufacturer · US , Walker , MI

Richards Medical Co., Inc.

71 submissions · 59 cleared · Since 1983
71
Total
59
Cleared
0
Denied

Richards Medical Co., Inc. — FDA 510(k) Submissions

Richards Medical Co., Inc. has submitted 71 FDA 510(k) premarket notifications since 1983, of which 59 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Tube, Tympanostomy, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented . Use the specialty filter in the sidebar to narrow results.

71 devices
1–25 of 71
ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
K896106 · KWP Appliance, Fixation,... · Orthopedic
Jun 1990 248d
MODULAR HIP SYSTEM
K900628 · LZO Prosthesis, Hip,... · Orthopedic
May 1990 90d
UNI-POLAR HEAD
K896580 · LZY Prosthesis, Hip, Hemi-,... · Orthopedic
Feb 1990 90d
INTRAMEDULLARY HIP SCREW
K895241 · KTT Appliance, Fixation,... · Orthopedic
Jan 1990 136d
TRICON-M TOTAL KNEE SYSTEM
K884824 · MBV Prosthesis, Knee,... · Orthopedic
Nov 1989 368d
ZIRCONIA CERAMIC HEAD ADD'L SIZES
K896204 · LZO Prosthesis, Hip,... · Orthopedic
Nov 1989 25d
PAPPAS TRI-FLANGE VENTILATION TUBE
K895242 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Nov 1989 88d
RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
K893377 · HSB Rod, Fixation,... · Orthopedic
Nov 1989 199d
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069 · LZO Prosthesis, Hip,... · Orthopedic
Sep 1989 267d
POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
K890132 · JWH Prosthesis, Knee,... · Orthopedic
Jul 1989 188d
POROUS GENESIS STEMMED TIBIAL COMPONENT
K892366 · JWH Prosthesis, Knee,... · Orthopedic
Jul 1989 104d
POROUS COATED GENESIS FEMORAL COMPONENT
K885036 · JWH Prosthesis, Knee,... · Orthopedic
Apr 1989 135d
ROGOZINSKI SPINAL SYSTEM
K884263 · KWP Appliance, Fixation,... · Orthopedic
Dec 1988 79d
MODULAR COLLARED HJD TOTAL HIP SYSTEM
K884457 · JDI Prosthesis, Hip,... · Orthopedic
Nov 1988 24d
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
K882244 · EPP Splint, Nasal · Ear, Nose, Throat
Jun 1988 23d
HJD CALCAR REPLACEMENT PROSTHESIS
K881769 · JDI Prosthesis, Hip,... · Orthopedic
Jun 1988 65d
IMPULSE TVC (RICHARDS, OMNI, MARCON)
K881143 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1988 62d
RESUBMITTING OF HJD TOTAL HIP SYSTEM
K881117 · JDI Prosthesis, Hip,... · Orthopedic
Apr 1988 51d
ADDVANTAGE:TVC MARCON
K880284 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1988 32d
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP
K880285 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1988 29d
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
K880286 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1988 29d
SPECTRON EF ACETABULAR COMPONENT
K874619 · JDI Prosthesis, Hip,... · Orthopedic
Feb 1988 100d
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868 · JDG Prosthesis, Hip, Femoral... · Orthopedic
Jan 1988 60d
STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM
K875156 · JDQ Cerclage, Fixation · Orthopedic
Jan 1988 36d
ENDOSCOPES FOR SINUS SURGERY
K874215 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Jan 1988 80d
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