meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
32
Latest Decision
1994-11-01

Clearances · page 105 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K944472 CURVD ENDOPHOTOCOGULATOR LASER PROBE Mnlase, Inc. GEX Class II 1994-11-01
K944624 MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER Mnlase, Inc. GEX Class II 1994-11-01
K944784 MINI-OP LAPAROSCOPIC LASSO Uresil Corp. GEI Class II 1994-10-28
K934630 UNIVERSAL VIDEO/LASER ARM DRAPE Hydro-Med Products, Inc. KKX Class II 1994-10-28
K926463 RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES Midmark Corp. FQO Class I 1994-10-21
K944706 REDA LAPAROSCOPIC INSTRUMENTS GER-MAIN PRIME ENDO LAPAROSCOPIC INSTRUMENTS Reda Instrumente GmbH GEI Class II 1994-10-20
K944855 CHROMOPHARE Berchtold Holding GmbH FSY Class II 1994-10-19
K943644 IMPLANTECH TEMPORAL IMPLANT Implantech Associates, Inc. FWP Class II 1994-10-18
K942472 PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123 Protectaide, Inc. FXX Class II 1994-10-18
K942476 PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069 Protectaide, Inc. FXX Class II 1994-10-18
K942471 PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777 Protectaide, Inc. FXX Class II 1994-10-18
K942473 PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592 Protectaide, Inc. FXX Class II 1994-10-18
K942475 PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351 Protectaide, Inc. FXX Class II 1994-10-18
K942474 PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 Protectaide, Inc. FXX Class II 1994-10-18
K942470 PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315 Protectaide, Inc. FXX Class II 1994-10-18
K943342 MEDICAM XENON LIGHT SOURCE M.P. Video, Inc. FSW Class II 1994-10-17
K943288 AMSCO SQ240 SURGICAL LIGHT American Sterilizer Co. FSY Class II 1994-10-17
K944779 CARBON LIGHTS HAND SURGERY TABLE Allen Medical Systems, Inc. FWZ Class I 1994-10-14
K944317 GENESIS 2000 Ion Laser Technology GEX Class II 1994-10-11
K944775 ELECTROSURGICAL UNIT MODEL 26-0335 Cameron-Miller, Inc. GEI Class II 1994-10-11
K942108 COHORT BONE BRUSH Advanced Med/Surg, Inc. HWE Class I 1994-10-11
K944206 GENESIS 2000 Ion Laser Technology GEX Class II 1994-10-11
K944091 THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS Lca, Inc. GEX Class II 1994-10-07
K931562 GUARDIAN SURGEON'S GOWNS Atkins Healthcare Services FYA Class II 1994-10-07
K923960 UPPER EXTERMITY DRAPE KIT Medikmark, Inc. KKX Class II 1994-10-07
K944530 KARL STORZ INSULATED SCISSORS AND RECTAL SNARES KARL STORZ Endoscopy-America, Inc. GEI Class II 1994-10-07
K944707 ISOLATED CAMERA HEAD Envision Medical Corp. FWF Class I 1994-10-07
K931914 SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE Surgimetrics International, Ltd. GAR Class II 1994-10-05
K940396 WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) Boston Scientific Scimed, Inc. ESW Class II 1994-10-03
K944044 CHIBA STYLE BIOPSY NEEDLE Kormed, Inc. LRO Class II 1994-10-03
K944370 O-R-EZ TIP CLEANER O-R-Ez, Inc. GEI Class II 1994-10-03
K935199 SURGICAL APPAREL Associated Hospital Services, Inc. KKY Class II 1994-09-30
K944090 CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER Candela Laser Corp. GEX Class II 1994-09-30
K943871 AQUAPLAST TIE DOWN DRESSING Wfr/Aquaplast Corp. LZM Class I 1994-09-30
K943479 GENEMED YAG 1000 MEDICAL LASER Genemed, Inc. GEX Class II 1994-09-29
K944617 SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL Unimed Surgical Products, Inc. GEI Class II 1994-09-29
K922452 GORE-TEX SOFT TISSUE PATCH PLUS W. L. Gore & Associates, Inc. FTL Class II 1994-09-29
K942934 CONBIO CUB-D10 COOPER LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1994-09-27
K942944 IRRIGATION/BIPOLAR SET Surgin Surgical Instrumentation, Inc. GEI Class II 1994-09-27
K940226 SHOE COVER Derekduck Industries Corp. LYU Class I 1994-09-26
K940228 BOUFFANT CAP Derekduck Industries Corp. LYU Class I 1994-09-26
K944433 SURGI-LINK ELECTROSURGICAL ELECTRODE Unimed Surgical Products, Inc. GEI Class II 1994-09-26
K943378 IMPLEX CEMENT RESTRICTOR SYSTEM Implex Corp. LZN Class II 1994-09-23
K943865 FORCE GSU-SLPM SYSTEM Valleylab, Inc. GEI Class II 1994-09-23
K942956 SURGICAL INSTRUMENTS AND ACCESSORIES Stryker Corp. HWE Class I 1994-09-23
K942579 FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22 Valleylab, Inc. GEI Class II 1994-09-21
K942060 P.F.C. CEMENT RESTRICTOR Johnson & Johnson Professionals, Inc. LZN Class II 1994-09-20
K940395 WALLSTENT ESOPHAGEAL PROSTHESIS Boston Scientific Scimed, Inc. ESW Class II 1994-09-20
K943171 CROSSFIRE(TM) (705-10650) Cardiogenes GEX Class II 1994-09-20
K932595 ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR Johnson & Johnson Orthopaedics, Inc. LZN Class II 1994-09-20
K943399 THE SS-99 Instantron KCW Class I 1994-09-16
K943398 THE BLENDTONE ROYALE Instantron KCW Class I 1994-09-16
K942786 KARL STORZ LASER ACCESSORIES KARL STORZ Endoscopy-America, Inc. GEX Class II 1994-09-16
K943396 THE ELITE SPECTRUM Instantron KCW Class I 1994-09-16
K931143 AMSCO STERILE RECOVERIES ABSORBENT TOWELS Amsco Sterile Recoveries, Inc. KKX Class II 1994-09-08
K944045 SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPS Unimed Surgical Products, Inc. GEI Class II 1994-09-08
K942660 HALL MICROCHOICE ELECTRIC POWERED SYSTEM Hall Surgical, Division of Zimmer, Inc. HWE Class I 1994-09-07
K943122 SURGICAL DRAPES Mallinckrodt Group, Inc. KKX Class II 1994-09-07
K944116 FREEDOM ASPIRATOR, MODEL 6000 Stackhouse, Inc. BTA Class II 1994-09-07
K944015 HARPO SUNBED, SUN TANNING MACHINE Harpo Industries LEJ Class II 1994-09-06
K942760 PNEUMATIC WIRE TENSIONER Smith & Nephew Richards, Inc. HSZ Class I 1994-09-06
K920596 FULL SPECTRUM ULE FIBER, MODEL FF101 Gerald J. Shirk, M.D. GEX Class II 1994-09-06
K940723 BODY BOOT Mark-Clark LYU Class I 1994-09-06
K942542 SLASE 210 PLUS HOLMIUM LASER SYSTEM Sunrise Technologies, Inc. GEX Class II 1994-09-01
K943991 O-R-EZ TIP CLEANER O-R-Ez, Inc. GEI Class II 1994-09-01
K932918 TOTAL KNEE KIT Biodynamic Technologies, Inc. HWE Class I 1994-09-01
K934811 PLTL-1 & PLDL-1 510NM PULSED DYE LASERS Candela Laser Corp. GEX Class II 1994-09-01
K943542 ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE Conmedcorp GEI Class II 1994-09-01
K942759 OPTICON(TM) CONNECTOR ADAPTER II Xintec Corporation GEX Class II 1994-08-31
K934501 LASER PHOTONICS ML755 DERMABLASER Laser Photonics, Inc. GEX Class II 1994-08-30
K943818 MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS R-Med, Inc. GEI Class II 1994-08-29
K941907 APEX DISPOSABLE INSTRUMENTS Apex Ent., Inc. MDM Class I 1994-08-26
K942204 ARGON CURING LASER Bio-Laser Technology, Inc. GEX Class II 1994-08-26
K943444 MEGABEAM LATERAL FIRE Ceram Optec, Inc. GEX Class II 1994-08-26
K934208 SLT PRISM/REFRACTING PROBE Surgical Laser Technologies, Inc. GEX Class II 1994-08-26
K933757 HAND-HELD IRRIGATION PUMP Ximed Medical Systems BTA Class II 1994-08-26
K943526 MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM Ceram Optec, Inc. GEX Class II 1994-08-26
K943445 MEGABEAM FIBER OPTIC DELIVERY SYSTEM Ceram Optec, Inc. GEX Class II 1994-08-26
K942818 DEEP SUTURE Automated Medical Products Corp. MDM Class I 1994-08-25
K933918 SHARPLAN MODEL 1080S CO2 SURGICAL LASER Sharplan Lasers, Inc. GEX Class II 1994-08-25
K941681 ARTHREX CIRCULAR HARVESTING SAW Arthrex, Inc. HSZ Class I 1994-08-25
K942606 SURGICAL STAPLE United States Surgical, A Division of Tyco Healthc GDW Class II 1994-08-24
K943719 VISISTAT STAPLER Pilling Weck, Inc. GDT Class I 1994-08-24
K940750 INNERVISION,INC. LAPAROSCOPIC ELECTRODES Innervision, Inc. GEI Class II 1994-08-23
K935631 CONBIO MEDALEX LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1994-08-23
K943409 SIDE-FIRING UROLOGIC REFRACTIVE FIBER Energy Life Systems Corp. GEX Class II 1994-08-23
K942865 LASER GAS MIXTURE Nordan Smith Welding Supplies GEX Class II 1994-08-23
K941299 FLARED PATCH Flared Patch, Inc. FTL Class II 1994-08-23
K943758 SURGICAL BUR Komet Medical GFF Class I 1994-08-22
K943693 PULSEMASTER S SERIES Incisive Technologies, Inc. GEX Class II 1994-08-22
K943229 DISPOSABLE SURGICAL SCISSORS AND FORCEPS Y.M.K. International Co., Ltd. KDC Class I 1994-08-19
K940838 MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM Boston Scientific Corp ESW Class II 1994-08-18
K941227 SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL Instantron KCW Class I 1994-08-18
K941960 IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II Implantech Associates, Inc. FZE Class II 1994-08-17
K941337 FLOWGUN ELECTROCAUTERY PROBES O.R. Concepts, Inc. GEI Class II 1994-08-17
K943159 LIFE CLIP AND LIFE CLIP APPLIER Life Surgery, Inc. FZP Class II 1994-08-16
K942627 454A ELECTROSURGICAL ANALYZER Hogan & Hartson GEI Class II 1994-08-15
K941841 SMARTSCAN Laserscope GEX Class II 1994-08-15
K943656 ALPHA SOLAR SYSTEM TANNING BED Heartland Tan Systems LEJ Class II 1994-08-15
K941197 SILK*SKIN SCAR TREATMENT Puritas Health Care, Inc. MDA Class I 1994-08-11

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.