ClearanceBrief
Panels › Orthopedic › Product code HRX · Class 2

Arthroscope

Regulation 888.1100

10510(k)s in 12 months (685 all time)
0recalls in 12 months (126 all time)
103recalls that name a 510(k)
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Top companies in HRX

Decided510(k)Device and applicantCode
Oct 15, 2007K072675SMITH & NEPHEW ARTHROSCOPE
Smith & Nephew, Inc.
HRX
Apr 2, 2007K070233CONMED LINVATEC SMART GUARD IRRIGATOR
Conmed Linvatec
HRX
Jan 31, 2007K063326CONMED LINVATEC 24K IRRIGATION SYSTEM
Conmed Linvatec
HRX
Jan 19, 2007K062849SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
Smith & Nephew, Inc.
HRX
Dec 19, 2006K062038X-STEN MILD TOOL KIT, MODEL MTK-0001
X-Sten Corp.
HRX
Dec 14, 2006K062380FLOSIMPLE ARTHROSCOPY PUMP A120
W.O.M. World of Medicine AG
HRX
Sep 1, 2006K061134EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
Efs Eberle Feinwerktechnische Systeme
HRX
Aug 23, 2006K061246ENDOSCOPIC SPINE SYSTEM
Arthro Kinetics, Inc.
HRX
Jun 6, 2006K061345MODIFICATION TO ENDIUS ATAVI SYSTEM
Endius, Inc.
HRX
May 31, 2006K060172REMA SHAVER BLADES
Rema Medizintechnik GmbH.
HRX
May 11, 2006K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
Linvatec Corp.
HRX
Mar 6, 2006K053567ATHROCARE TOPAZ ARTHROWANDS
Arthrocare Corp.
HRX
Feb 24, 2006K052241DISC-FX SYSTEM
Ellman International, Inc.
HRX
Jan 13, 2006K053267ENDIUS ATAVI SYSTEM
Endius, Inc.
HRX
Oct 25, 2005K051656OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
Osteobiologics, Inc.
HRX
Aug 12, 2005K051827JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE
Joimax GmbH
HRX
Jun 15, 2005K051326SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
Smith & Nephew, Inc.
HRX
Apr 20, 2005K050580SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
Smith & Nephew Endoscopy, Inc.
HRX
Jan 25, 2005K043568EQUESTRA FLUID DELIVERY SYSTEM
Medtronic Sofamor Danek
HRX
Jan 12, 2005K043395SMITH & NEPHEW VIDEOARTHROSCOPE
Smith & Nephew, Inc.
HRX
Jan 7, 2005K041824X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
Future Medical Systems, SA, FR
HRX
Jul 28, 2004K041233ARTHROJET XT
Hydrocision, Inc.
HRX
Jul 23, 2004K040483EQUESTRA FLUID DELIVERY SYSTEM
Medtronic Sofamor Danek, Inc.
HRX
Jul 9, 2004K041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
Kyphon, Inc.
HRX
Jun 17, 2004K040612SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Disc-O-Tech Medical Technologies, Ltd., IL
HRX
Jun 1, 2004K040919NUCLEOTOME PROBE SET, MODEL 21200
Clarus Medical, LLC
HRX
May 12, 2004K040939SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Disc-O-Tech Medical Technologies, Ltd., IL
HRX
May 10, 2004K041135VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
Depuy Mitek, A Johnson & Johnson Company
HRX
Feb 11, 2004K033573LINVATEC 10K IRRIGATION SYSTEM
Linvatec Corp.
HRX
Jan 28, 2004K034037SKY BONE EXPANDER SYSTEM
Disc-O-Tech Medical Technologies, Ltd.
HRX
Jan 15, 2004K033927ARTHOSCOPY PUMP A115
W.O.M. World of Medicine AG
HRX
Jan 15, 2004K032891TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
Trans1, Inc.
HRX
Dec 17, 2003K032358B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
Disc-O-Tech Medical Technologies, Ltd.
HRX
Nov 7, 2003K032473DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
Stryker Instruments
HRX
Oct 30, 2003K030082POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
Richard Wolf Medical Instruments Corp.
HRX
Sep 26, 2003K032832IRRIGATION SETS
Vital Concepts, Inc.
HRX
Sep 16, 2003K032529HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310
Hydrocision, Inc.
HRX
Sep 15, 2003K032212KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
Kyphon, Inc.
HRX
Sep 15, 2003K031972ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
Asap Endoscopic Products GmbH, DE
HRX
Jun 18, 2003K031605INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
Smith & Nephew, Inc.
HRX
May 30, 2003K031406EXOJET TISSUE MANAGEMENT SYSTEM
Mitek Worldwide
HRX
Apr 17, 2003K030402ARTHROSCOPY PUMP, MODEL A107
W.O.M. World of Medicine AG
HRX
Apr 2, 2003K030009KSEA POWERSHAVER SYSTEM S2
Karl Storz Endoscopy
HRX
Mar 20, 2003K024291ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
Arthrex, Inc.
HRX
Mar 18, 2003K030096VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
Arthrex, Inc.
HRX
Feb 20, 2003K030196DYONICS POWER CONTROL UNIT
Smith & Nephew, Inc.
HRX
Feb 13, 2003K030307DAVOL ARTHROVENT OUTFLOW TUBING
Davol, Inc.
HRX
Feb 7, 2003K023783SOHNIKS
Sohniks Endoscopy, Inc.
HRX
Dec 11, 2002K023777ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
Arthronet Medical, Inc.
HRX
Dec 2, 2002K023187KSEA SPINOSCOPE
Karl Storz Endoscopy
HRX

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