ClearanceBrief
Company ยท US

Smith & Nephew Richards, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1997. Name variants (Inc, Corp, punctuation) are merged.

87510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer8
ETBProsthesis, Partial Ossicular Replacement7
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented7
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component5
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4
ETAReplacement, Ossicular Prosthesis, Total3
HSBRod, Fixation, Intramedullary And Accessories3
HWCScrew, Fixation, Bone3
KWPAppliance, Fixation, Spinal Interlaminal3
LYASplint, Intranasal Septal3
EMXBalloon, Epistaxis2
ETDTube, Tympanostomy2
HRSPlate, Fixation, Bone2
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment2
KAMCannula, Sinus2
KWQAppliance, Fixation, Spinal Intervertebral Body2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2
MNHOrthosis, Spondylolisthesis Spinal Fixation2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 8, 1997K965224EMPOWER ANTERIOR DIRECT SCREWS
Smith & Nephew Richards, Inc.
KWP
Jan 27, 1997K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
Smith & Nephew Richards, Inc.
LPH
Jan 24, 1997K960444FINN ROD TO ROD CONNECTOR
Smith & Nephew Richards, Inc.
KWP
Dec 27, 1996K964163TRIMAX NAIL SYSTEM
Smith & Nephew Richards, Inc.
HSB
Dec 5, 1996K962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
Smith & Nephew Richards, Inc.
JWH
Nov 27, 1996K963486REVISION HIP SYSTEM
Smith & Nephew Richards, Inc.
JDI
Sep 17, 1996K962541REFLECTION ACETABULAR REINFORCEMENT RINGS
Smith & Nephew Richards, Inc.
JDJ
Aug 19, 1996K962808ILIZAROV EXTERNAL FIXATION SYSTEM
Smith & Nephew Richards, Inc.
KTT
Aug 2, 1996K962137GENESIS II CONSTRAINED SYSTEM
Smith & Nephew Richards, Inc.
JWH
Apr 8, 1996K955767COFIED MODULAR SHOULDER SYSTEM
Smith & Nephew Richards, Inc.
KWS
Mar 27, 1996K960094REFLECTION DUAL DIMENSION SHELL
Smith & Nephew Richards, Inc.
MBL
Mar 11, 1996K954696ROGOZINSKI THORACOLUMBAR SPINAL ROD
Smith & Nephew Richards, Inc.
KWP
Feb 5, 1996K953274GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
Smith & Nephew Richards, Inc.
JWH
Jan 31, 1996K954909PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
Smith & Nephew Richards, Inc.
JWH
Jan 5, 1996K955552EXPRESSAIRE TORUNIQUET SYSTEM
Smith & Nephew Richards, Inc.
KCY
Nov 15, 1995K954491HYDROCELL NASAL AND SINUS PACKS
Smith & Nephew Richards, Inc.
EMX
Oct 31, 1995K954712INTRAMEDULLARY HIP SCREW (MODIFICATION)
Smith & Nephew Richards, Inc.
KTT
Oct 31, 1995K953397HEX-FIX FIELD FIXATOR
Smith & Nephew Richards, Inc.
LXT
Sep 12, 1995K952697TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
Smith & Nephew Richards, Inc.
HWC
Sep 8, 1995K952271GENESIS CONSTRAINED SYSTEM (GCS)
Smith & Nephew Richards, Inc.
JWH
Sep 1, 1995K950865ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT
Smith & Nephew Richards, Inc.
MNH
Aug 22, 1995K951987GENESIS II TOTAL KNEE SYSTEM
Smith & Nephew Richards, Inc.
JWH
Aug 15, 1995K950093AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES
Smith & Nephew Richards, Inc.
HRX
Aug 8, 1995K946088GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM
Smith & Nephew Richards, Inc.
JWH
Jul 28, 1995K953096ESSENTIAL SHAVER SYSTEM
Smith & Nephew Richards, Inc.
EQJ
Jul 24, 1995K951389REUNION BONE SCREW SYSTEM
Smith & Nephew Richards, Inc.
HWC
Jul 6, 1995K946236PROFIX CONFORMING PLUS TIBIAL INSERT
Smith & Nephew Richards, Inc.
KWH
Jul 3, 1995K952549RICHARDS TORP
Smith & Nephew Richards, Inc.
ETA
Jun 16, 1995K952481RICHARDS PORP
Smith & Nephew Richards, Inc.
ETB
Jun 14, 1995K934590IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
Smith & Nephew Richards, Inc.
HWC
Jun 14, 1995K930298ROGOZINSKI SPINAL ROD SYSTEM SCREW
Smith & Nephew Richards, Inc.
MNH
Jun 7, 1995K952207NASAL SEPTAL SPLINT
Smith & Nephew Richards, Inc.
LYA
May 19, 1995K950394TIBIA-TALUS-CALCANEUS NAIL
Smith & Nephew Richards, Inc.
HSB
May 11, 1995K951803ROSSITER SINUS STENT
Smith & Nephew Richards, Inc.
KAM
Apr 4, 1995K951066RAINS FRONTAL SINUS STENT
Smith & Nephew Richards, Inc.
KAM
Mar 23, 1995K935235ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
Smith & Nephew Richards, Inc.
GCM
Mar 21, 1995K950927HAPEX MALLEABLE TORP
Smith & Nephew Richards, Inc.
ETA
Mar 15, 1995K950984HAPES MALLEABLE INCUS STAPES
Smith & Nephew Richards, Inc.
ETB
Mar 15, 1995K950887HAPEX INCUS
Smith & Nephew Richards, Inc.
ETB
Mar 15, 1995K950886HAPEX PORP
Smith & Nephew Richards, Inc.
ETB
Mar 15, 1995K950885HAPEX MALLEABLE PORP
Smith & Nephew Richards, Inc.
ETB
Jan 9, 1995K933958RICHARDS TOTAL KNEE SYSTEM
Smith & Nephew Richards, Inc.
JWH
Dec 19, 1994K943523ANTERIOR CERVIAL PLATING SYSTEM
Smith & Nephew Richards, Inc.
KWQ
Nov 28, 1994K935921ZIRCONIA CERAMIC FEMORAL HEAD
Smith & Nephew Richards, Inc.
LZO
Sep 6, 1994K942760PNEUMATIC WIRE TENSIONER
Smith & Nephew Richards, Inc.
HSZ
Aug 19, 1994K931131THE RICHARDS WRIST
Smith & Nephew Richards, Inc.
JWJ
Aug 1, 1994K936233PELVIC RADIUS PLATE
Smith & Nephew Richards, Inc.
HRS
Jul 20, 1994K934733STIMULATING SURGICAL INSTRUMENTS
Smith & Nephew Richards, Inc.
ETN
Jul 18, 1994K941264RICHARD ROD LENS LARYNGOSCOPE
Smith & Nephew Richards, Inc.
EOQ
Jun 15, 1994K930480VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
Smith & Nephew Richards, Inc.
HRS

Newest 50 of 87.

Latest recalls

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