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
Apr 1, 1991K905014AMSET PLD SYSTEM
Advanced Med/Surg, Inc.
HRX
Mar 27, 1991K910164ORTHOCONCEPT ARTHROSCOPIC PUMP
Orthoconcept, Inc.
HRX
Mar 26, 1991K905785ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)
Orthoconcept, Inc.
HRX
Mar 15, 1991K904859MOTOR DRIVEN EXTIRPATION INSTRUMENTS
Aesculap, Inc.
HRX
Dec 20, 1990K904465FLEXIBLE ARTHROSCOPE
Intramed Laboratories, Inc.
HRX
Dec 5, 1990K904284ARTHROSCOPIC SURGICAL BLADE
Smith & Nephew Dyonics, Inc.
HRX
Nov 2, 1990K904479SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015
Percutaneous Technologies
HRX
Oct 30, 1990K902778SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER
Surgical Dynamics, Inc.
HRX
Oct 26, 1990K904720POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES
Baxter Healthcare Corp
HRX
Oct 22, 1990K900616SHEPPERD CUTTING FORCEPS
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900615SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900614SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900613SHEPPERD SHELTER TUBE COMPLETE & DRILL
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900612SHEPPERD TREPHINE SET (GS-501-30-V)
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900611SHEPPERD DILATATION TUBE SET (GS-501-20-H)
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900610SHEPPERD CANNULA STILLETTE & OBDURATOR SET
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900609SHEPPERD STRAIGHT AND CURVED NEEDLES
Downs Surgical , Ltd., GB
HRX
Oct 22, 1990K900608SHEPPERD LUMBAR DISCECTOMY SYSTEM
Downs Surgical , Ltd., GB
HRX
Oct 19, 1990K903312CYGNASCOPE
Cygnus Instruments, Inc.
HRX
Oct 12, 1990K903620MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM
Smith & Nephew Dyonics, Inc.
HRX
Jun 25, 1990K901765POSTEROMEDIAL GUIDE
Smith & Nephew Dyonics, Inc.
HRX
Jun 20, 1990K902168ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
Micro-Aire Surgical Instruments, Inc.
HRX
Jun 20, 1990K901735ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
Micro-Aire Surgical Instruments, Inc.
HRX
May 29, 1990K901617ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)
Smith & Nephew, Inc.
HRX
May 3, 1990K900812MEDICAM ARTHROSCOPE SYSTEMS
Kirschner Medical Corp.
HRX
Apr 18, 1990K901505ARTHROSCOPIC ELECTROSURGICAL PROBE
Smith & Nephew Dyonics, Inc.
HRX
Mar 29, 1990K900680EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS
Effner, Inc.
HRX
Feb 16, 1990K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM
Dyonics, Inc.
HRX
Jan 30, 1990K896678SILICONE PLUG
Orthopedic Systems, Inc.
HRX
Jan 2, 1990K896770ARTHRODISTRACTOR
Arthroplastics, Inc.
HRX
Jan 2, 1990K896416DYONICS SHOULDER PORTAL SYSTEM
Dyonics, Inc.
HRX
Dec 27, 1989K896584ARTHROSCOPIC TUBING SHEATH
Origin Medsystems, Inc.
HRX
Dec 14, 1989K893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY
Dyonics, Inc.
HRX
Dec 6, 1989K896538DISPOSABLE 45 DEGREE SHAVER
Bowen & Company, Inc.
HRX
Dec 1, 1989K896196ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR
Orthoconcept, Inc.
HRX
Nov 8, 1989K894990DAVOL ARTHROSCOPY CANNULA
Davol, Inc.
HRX
Nov 3, 1989K890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES
Dyonics, Inc.
HRX
Oct 16, 1989K895685SMALL JOINT HAND INSTRUMENTS
Leonard Medical, Inc.
HRX
Aug 18, 1989K894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE
Dyonics, Inc.
HRX
Aug 7, 1989K894558MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
Optik
HRX
Aug 1, 1989K892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
Concept, Inc.
HRX
Jul 25, 1989K894303MEDSCOPE 4MM ARTHROSCOPE
Medscope Corp.
HRX
Jun 23, 1989K892062PS3500 ARTHROSCOPIC SURGICAL SYSTEM
Dyonics, Inc.
HRX
Mar 13, 1989K884314LEONARD MEDICAL 1.7MM ARTHROSCOPE
Leonard Medical, Inc.
HRX
Mar 13, 1989K884301EDWARDS DISPOSABLE ARTHROSCOPY CANNULA
Baxter Healthcare Corp
HRX
Mar 9, 1989K885183ENDOSCOPIC LIGHT SOURCE
Technology For Imaging, Inc.
HRX
Jan 30, 1989K875130BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS
Orthopedic Systems, Inc.
HRX
Dec 1, 1988K882469CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES
Orthoconcept, Inc.
HRX
Nov 30, 1988K884302EDWARDS ARTHROSCOPIC LEG HOLDER
Baxter Healthcare Corp
HRX
Nov 1, 1988K883300IRRIGATION SET
Edwards Orthopaedics Div., Baxter Healthcare Corp.
HRX

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