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
May 19, 1994K941269GORE SMOOTHER II AND GORE BPTB
W. L. Gore & Associates, Inc.
HRX
May 18, 1994K936213ARTHROSCOPES AND ACCESSORIES
Micro-Medical Devices, Inc.
HRX
May 16, 1994K941364ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS
Acufex Microsurgical, Inc.
HRX
May 16, 1994K940985ACUFEX(R) ARTHROPLASTY INSTRUMENTS
Acufex Microsurgical, Inc.
HRX
May 16, 1994K940981ACUFEX LINEAR/ROTARY INSTRUMENTS
Acufex Microsurgical, Inc.
HRX
May 6, 1994K940481ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM
Acufex Microsurgical, Inc.
HRX
Apr 28, 1994K935221STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS
Stryker Endoscopy
HRX
Apr 28, 1994K931323MOUNTABLE KNIFE
Esco Medical
HRX
Apr 26, 1994K940623ACUFEX SURETAC IXC SYSTEMS
Acufex Microsurgical, Inc.
HRX
Apr 26, 1994K940506ACUFEX ARTHROSCOPIC SUTURE CUTTER
Acufex Microsurgical, Inc.
HRX
Apr 21, 1994K933576ARTHROSCOPE, DISPOSABLE
United States Surgical, A Division of Tyco Healthc
HRX
Apr 15, 1994K940075SHAVER BLADE SET
Arthrex, Inc.
HRX
Apr 15, 1994K934379LINVATEC POWERLINK SURGICAL SHAVING SYSTEM
Linvatec Corp.
HRX
Apr 15, 1994K921119ARTHREX ARTHROSCOPE
Arthrex, Inc.
HRX
Mar 31, 1994K931076ARTHOSCOPE AND ACCESSORIES
Meditron Devices, Inc.
HRX
Mar 29, 1994K931109NUCLEOTOME E KIT
Surgical Dynamics, Inc.
HRX
Mar 29, 1994K922519MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
Smith & Nephew, Inc.
HRX
Mar 25, 1994K940454GRASPING FORCEPS, PUNCHES, SCISSORS
L.A.S.E.R., Inc.
HRX
Mar 25, 1994K934720AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE
United States Surgical, A Division of Tyco Healthc
HRX
Mar 25, 1994K934332SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES
Friatec Medical Inc., USA
HRX
Mar 25, 1994K933470ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM
Kinetix Instruments
HRX
Mar 25, 1994K932869ARTHROPLANE
Synvasive Technology, Inc.
HRX
Mar 24, 1994K934401ARTHROTEK CANNULA SYSTEM
Biomet, Inc.
HRX
Mar 24, 1994K933638ACUMED CARPAL TUNNEL RELEASE KIT
Acu Med, Inc.
HRX
Mar 24, 1994K933070ARTHTOTEK PRECISION HAND INSTRUMENTATION
Biomet, Inc.
HRX
Mar 23, 1994K936206GORE SMOOTHER CRUCIAL TOOL
W. L. Gore & Associates, Inc.
HRX
Mar 23, 1994K934181ACUFEX ADJUSTABLE-LENGTH CANNULA
Acufex Microsurgical, Inc.
HRX
Mar 22, 1994K932460ACUFEX MENISCAL RASPS
Acufex Microsurgical, Inc.
HRX
Mar 21, 1994K932718ACUFEX METAL ACL CANNULA
Acufex Microsurgical, Inc.
HRX
Mar 18, 1994K933949DISPOSABLE ARTHROSCOPIC ACCESSORY
United States Surgical, A Division of Tyco Healthc
HRX
Mar 11, 1994K930152ARTHREX TIBIAL TUNNEL CANNULA
Arthrex, Inc.
HRX
Feb 17, 1994K925160ARTHRO FMS 4
Orthoconcept, Inc.
HRX
Feb 14, 1994K934299DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
Smith & Nephew Dyonics, Inc.
HRX
Feb 14, 1994K934270ACUFEX ARTHROSCOPE
Acufex Microsurgical, Inc.
HRX
Jan 31, 1994K926212ARTHREX INSTRUMENTS ( HIP )
Arthrex, Inc.
HRX
Jan 26, 1994K926303ARTHREX INSTRUMENTS (WRIST)
Arthrex, Inc.
HRX
Jan 21, 1994K931621ACUFEX PRO-PAC AND ISO-PAC
Acufex Microsurgical, Inc.
HRX
Jan 7, 1994K923514CLARUS SERIES 2100 ENDOSCOPE
Clarus Medical Systems, Inc.
HRX
Dec 6, 1993K924016SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
Symbiosis Corp.
HRX
Oct 12, 1993K922486DANEK TISSUE CUTTING AND REMOVAL SYSTEM
Sofamor Danek Mfg., Inc.
HRX
Aug 3, 1993K922321OMNI ARTHROSCOPE
Expanded Optics, Inc.
HRX
Jul 28, 1993K925226SIGHT-PLUS ARTHROSCOPE
American Medical Concepts, Inc.
HRX
Jun 29, 1993K921985ARTHROSCOPE & ACCESSORIES
Optimed Technologies, Inc.
HRX
Jun 8, 1993K923069RESTORE TUNNEL PLUG
Depuy, Inc.
HRX
Jun 7, 1993K924773BURTON H- BASE TABLE - MODEL 1990
R.H. Burton Co.
HRX
May 26, 1993K924494CITSCOPE, BENDABLE -- MODIFICATION
Citation Medical Corp.
HRX
May 5, 1993K925573ACUFEX T-BAR
Acufex Microsurgical, Inc.
HRX
Apr 27, 1993K925083ENDOTRAK SYSTEM
Instratek, Inc.
HRX
Apr 8, 1993K925577DANEK TISSUE RESECTING SYSTEM
Sofamor Danek Mfg., Inc.
HRX
Apr 8, 1993K924144ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
Davol, Inc.
HRX

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