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

Company510(k)sRecalls
KARL STORZ Endoscopy-America, Inc.280
Arthrex, Inc.270
Stryker1215
Acufex Microsurgical, Inc.260
Ascent Healthcare Solutions022
Smith & Nephew192
Linvatec Corp.191
Stryker Endoscopy117
Linvatec Corp. dba ConMed Linvatec017
Richard Wolf Medical Instruments Corp.143
Decided510(k)Device and applicantCode
May 14, 1997K970562TENOSNARE
Luxtec Corp.
HRX
Mar 5, 1997K970055KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
KARL STORZ Endoscopy-America, Inc.
HRX
Mar 4, 1997K964879PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM
Davol Inc., Sub. C. R. Bard, Inc.
HRX
Feb 24, 1997K964975COHORT DISCECTOMY SYSTEMS (CDS)
Cohort Medical Products Group, Inc.
HRX
Jan 28, 1997K964919EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
Emerald Medical, Inc.
HRX
Jan 22, 1997K963304STRYKER TEMPEST ORTHOPEDIC PUMP
Stryker Endoscopy
HRX
Jan 17, 1997K962075HSW GMBH ARTHROSCOPE
Henke Sass Wolf of America, Inc.
HRX
Dec 20, 1996K964215ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
Smith & Nephew Endoscopy, Inc.
HRX
Nov 27, 1996K963029KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
KARL STORZ Endoscopy-America, Inc.
HRX
Nov 14, 1996K963524KSEA LARGE JOINT ARTHROSCOPY SET
Karl Storz Endoscopy
HRX
Oct 11, 1996K963332THERMO-PLASTIC SHAVER BLADES
Stryker Endoscopy
HRX
Oct 10, 1996K961228KARL STORZ MAGNIFYING ARTHROSOCPES
KARL STORZ Endoscopy-America, Inc.
HRX
Oct 8, 1996K961590APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
Linvatec Corp.
HRX
Sep 11, 1996K962330AMO ARTHOSCOPES
American Microptiks, Inc.
HRX
Sep 4, 1996K960194MYELOTEC MYELOSCOPE
Myelotec, Inc.
HRX
Aug 22, 1996K962114ARTHRO-SURGIMAT
W.O.M. World of Medicine GmbH
HRX
Jul 19, 1996K962321ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
Arthrocare Corp.
HRX
Jul 15, 1996K961747ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
Arthrocare Corp.
HRX
Jun 21, 1996K961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
Acufex Microsurgical, Inc.
HRX
May 31, 1996K961713INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY
KARL STORZ Endoscopy-America, Inc.
HRX
May 7, 1996K961244KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
KARL STORZ Endoscopy-America, Inc.
HRX
Apr 10, 1996K960805ARTHOSCOPE
United States Surgical, A Division of Tyco Healthc
HRX
Apr 2, 1996K960046SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE
Surgical Dynamics, Inc.
HRX
Mar 8, 1996K960222PERCUTANEOUS ENDOSCOPIC DISCECTOMY
Richard Wolf Medical Instruments Corp.
HRX
Feb 14, 1996K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
Aesculap, Inc.
HRX
Feb 9, 1996K955480BOZOTTA REINSERTION FORCEPS
KARL STORZ Endoscopy-America, Inc.
HRX
Feb 8, 1996K955914LIMITED REUSE ARTHROSCOPIC BLADES
Smith & Nephew Dyonics, Inc.
HRX
Feb 5, 1996K955500FMS ARTHOPROBE
Future Medical Systems, Inc.
HRX
Jan 25, 1996K954016VIDEOSCOPE W/IRRIGATION SHEATH
T. Korossurgical Instruments Corp.
HRX
Jan 22, 1996K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
Optus, Inc.
HRX
Jan 17, 1996K955652KARL STORZ TARGETING UNIT
KARL STORZ Endoscopy-America, Inc.
HRX
Dec 28, 1995K954964AQUACENTER 2000 SYSTEM
Aquarius Medical Corp.
HRX
Dec 18, 1995K955471INCL ENDOSCOPE
Sofamor Danek USA,Inc.
HRX
Dec 18, 1995K954627ECTRA II LIGAMENT RELEASE SYSTEM
Smith & Nephew Dyonics, Inc.
HRX
Dec 8, 1995K955273CANNULOC THREADED CANNULA
Linvatec Corp.
HRX
Dec 4, 1995K955272TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
KARL STORZ Endoscopy-America, Inc.
HRX
Dec 4, 1995K955037RIGID NEUROVIEW ENDOSCOPE
Neuro Navigational Corp.
HRX
Dec 4, 1995K954981KARL STORZ HEMPFLING DILATION SET
KARL STORZ Endoscopy-America, Inc.
HRX
Dec 4, 1995K953998DISCETOME TISSUE ASPIRATOR
T. Korossurgical Instruments Corp.
HRX
Nov 21, 1995K946087INCLUSICE II(TM) ENDOSCOPE
Sofamor Danek USA,Inc.
HRX
Nov 16, 1995K954882RIZA-RIBE NEEDLE (MODIFICATION)
R-Med, Inc.
HRX
Nov 14, 1995K954510RRIANGLE KNIFE
Phx Technologies Corp.
HRX
Nov 14, 1995K954509PROBE KNIFE
Phx Technologies Corp.
HRX
Nov 14, 1995K954508RETRACTOR
Phx Technologies Corp.
HRX
Nov 14, 1995K954507RETROGRADE KNIFE
Phx Technologies Corp.
HRX
Nov 9, 1995K954465FMS DUO
Future Medical Systems, Inc.
HRX
Nov 8, 1995K942029ARTHROSCOPE
Surgical Technologies, Inc.
HRX
Nov 6, 1995K954052ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES
T. Korossurgical Instruments Corp.
HRX
Nov 6, 1995K954014PERCUTANEOUS DISCECTOMY CANNULA SYSTEM
T. Korossurgical Instruments Corp.
HRX
Nov 2, 1995K954440APEX TUBING SET
Linvatec Corp.
HRX

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