meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
43
Latest Decision
1988-09-09

Clearances · page 132 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K882647 GESCO CATHETERIZATION TRAY Gesco Intl., Inc. GBQ Class I 1988-09-09
K882734 KTP/YAG(TM) SURGICAL LASER Laserscope GEX Class II 1988-09-09
K882926 MODEL AU-1 ACCESSORY UNIT Directed Energy, Inc. GEX Class II 1988-09-09
K883424 SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB Intera Corp. KKX Class II 1988-09-06
K882407 BOW & ARROW DRILL GUIDE Instrument Makar, Inc. LXI Class I 1988-09-06
K880534 ZEPHYR Racal Health & Safety, Inc. FXX Class II 1988-09-06
K883433 AMBU TWIN PUMP - (MANUAL SUCTION PUMP) Ambu, Inc. GCY Class I 1988-09-02
K882365 HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 Heraeus Lasersonics, Inc. GEX Class II 1988-09-02
K881936 OPER-FILM-ADHESIVE MEMBRANE Iberhospitex, S.A. NAD Class I 1988-08-31
K881731 AD-HEAL(TM) WOUND DRESSING Nepera, Inc. NAD Class I 1988-08-31
K882722 HOUVA-BED National Biological Corp. FTC Class II 1988-08-30
K882738 L.P.I. LASER DELIVERY SYSTEM Laser Photonics, Inc. GEX Class II 1988-08-30
K883250 STERI-CLENS WOUND CARE KIT Absorbent Cotton Co., Inc. LRO Class II 1988-08-26
K882772 LQ1106 OPHTHALMIC YAG LASER Keeler Instruments, Inc. GEX Class II 1988-08-26
K882696 DERMICEL, MONTGOMERY STRAP Bioseal NAD Class I 1988-08-26
K882000 PRO-FECT O.R. TOWEL Network Trading Corp. KKX Class II 1988-08-26
K883420 LANCET, BLOOD Primrose Medical, Inc. FMK Class II 1988-08-26
K882392 BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES Roseburg SA KGO Class I 1988-08-26
K883457 ASST-3000 SPINAL SURGERY TABLE Orthopedic Systems, Inc. FWY Class I 1988-08-26
K883303 MENTOR RAPID-SPAN (TM) TISSUE EXPANDER Mentor Corp. FZW Class I 1988-08-26
K883464 SURGICAL SHIRT Arkansas Lighthouse For the Blind FYA Class II 1988-08-26
K883244 PRISTINE XTRA, SURGEON'S GLOVE Japan World Medical Supply KGO Class I 1988-08-23
K883295 CHOP SPINE FRAME Avec Scientific Design Corp. LWG Class I 1988-08-23
K883299 SUTURE RETENTION DEVICE Edwards Orthopaedics Div., Baxter Healthcare Corp. KGS Class I 1988-08-23
K882942 LASER MIXTURE Swisco, Inc. GEX Class II 1988-08-23
K883098 SITE STERILIZATION TRAYS FOR OPHTHALMIC USE Site Microsurgical Systems, Inc. LRP Class I 1988-08-18
K882212 SLT CONTACT LASER SYSTEM Surgical Laser Technologies, Inc. GEX Class II 1988-08-17
K881624 PLEURAL BIOPSY PUNCH NEEDLE E.G. Dick & Assoc. GDM Class I 1988-08-11
K882882 C-MASK Promedica Products, Inc. FXX Class II 1988-08-10
K882883 C-MASK(FLAT) Promedica Products, Inc. FXX Class II 1988-08-10
K883193 CASF STERILIZATION TRAY Terray Manufacturing, Inc. FSM Class I 1988-08-10
K883125 CASF STERILIZATION TRAY Terray Manufacturing, Inc. FSM Class I 1988-08-10
K882963 SPEMBLY MEDICAL 142 CRYO UNIT Spembly Medical , Ltd. GEH Class II 1988-08-08
K882962 SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) Spembly Medical , Ltd. GEH Class II 1988-08-08
K881374 SURGEONS GLOVES Interpro Intl., Inc. KGO Class I 1988-08-05
K882049 MEDITRON MG-1000 MONOPOLAR GENERATOR Xylog Corp. GEI Class II 1988-08-05
K882958 SONY VIDEO PRINTERS, UP SERIES Sony Medical Electronics Co. KQM Class I 1988-08-04
K883060 STORZ MICROSURGICAL BIPOLAR COAGULATOR Storz Instrument Co. GEI Class II 1988-08-03
K882707 GAUZE PACKING, X-RAY DETECTABLE Bioseal GDY Class I 1988-08-03
K882684 REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. Standard Textile Co., Inc. LRO Class II 1988-08-03
K882708 GAUZE SPONGE, X-RAY DETECTABLE Bioseal GDY Class I 1988-08-03
K882208 MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES Linde Div. Union Carbide Corp. GEX Class II 1988-08-03
K882516 THREE-COMPONENT MEDICAL LASER GAS MIXTURES Matheson Gas Products, Inc. GEX Class II 1988-08-03
K883018 AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER United States Surgical, A Division of Tyco Healthc FZP Class II 1988-08-03
K882470 STERILE DISPOSABLE SURGICAL GOWNS Bolden Products, Div. of the Transport Group FYA Class II 1988-08-03
K882709 TONSIL SPONGE, X-RAY DETECTABLE, W/STRING Bioseal GDY Class I 1988-08-03
K882956 VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION Vital Metrics, Inc. HBI Class II 1988-08-03
K882724 MICROTEK PROBE DRAPE Microbio-Medics, Inc. KKX Class II 1988-08-03
K880816 MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM Niic U.S.A., Inc. GEX Class II 1988-08-01
K882240 STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC Storz Instrument Co. GDM Class I 1988-07-29
K882617 BREVET CASSETTE STERILIZATION MODULE Brevet, Inc. FSM Class I 1988-07-28
K883014 MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED Sherwood Medical Co. GAA Class I 1988-07-28
K882903 YESNG SUPER FRECATOR Ferguson Medical GEI Class II 1988-07-28
K882036 WILLIAMS ACS MARKER NEEDLE Buckman Co., Inc. GDF Class I 1988-07-27
K882924 MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS M.P. Video, Inc. KQM Class I 1988-07-26
K882660 GENERAL SURGICAL TABLE AND ACCESSORIES American Sterilizer Co. FQO Class I 1988-07-25
K882601 E-Z-EM(R) LUFKIN BIOPSY NEEDLES E-Z-Em, Inc. GDM Class I 1988-07-25
K881940 MODEL 20 KY KRYPTON YELLOW LASER Hgm Medical Laser Systems, Inc. GEX Class II 1988-07-20
K882742 FIBER OPTIC LIGHT SOURCE CAT. #E9100 Valleylab, Inc. GEI Class II 1988-07-18
K882613 ALM SURGICAL LAMPS Alm Surgical Equipment, Inc. FTD Class II 1988-07-18
K882073 SPINAL NEEDLE Karlin Technology, Inc. GDM Class I 1988-07-18
K882275 STERILE PACK (PROCEDURAL TRAY/KITS) East Texas Lighthouse For the Blind LRP Class I 1988-07-18
K882793 PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE Pmt Corp. GAF Class I 1988-07-18
K882520 SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS Karlin Technology, Inc. LWG Class I 1988-07-18
K882646 LECTROBRASIVE(R) E2401 Valleylab, Inc. GEI Class II 1988-07-18
K882010 POWER EXAMINATION TABLE Enochs Mfg., Inc. LGX Class I 1988-07-13
K874253 ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. Minnesota Laser Corp. LNK Class II 1988-07-12
K874255 ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. Minnesota Laser Corp. LNK Class II 1988-07-12
K882105 CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM Dianon Systems, Inc. GAA Class I 1988-07-11
K871512 SL-100 ND:YAG LASER FOR GYNECOLOGY USE Medical Energy, Inc. GEX Class II 1988-07-08
K882524 UNIVERSALLY ADJUSTABLE ARMBOARD Karlin Technology, Inc. BTX Class I 1988-07-08
K881619 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER Heraeus Lasersonics, Inc. GEX Class II 1988-07-08
K881913 PROTECTO-SHIELD Syntech Mfg. Services FXX Class II 1988-07-08
K882494 ELAN-E DISPOSALBE DRAPE Dermacare Products, Inc. KKX Class II 1988-07-08
K882381 PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI Pioneering Technologies, Inc. KGO Class I 1988-07-07
K881923 ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72 Ultraviolet Resources Intl. FTC Class II 1988-07-07
K882243 SPTL-1 PULSED DYE LASER Candela Laser Corp. GEX Class II 1988-07-05
K881349 VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM Cryosurg, Inc. GEH Class II 1988-06-30
K882346 INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD Nordbye, Milchman, Barlage FYF Class I 1988-06-30
K882421 INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE Dermacare Products, Inc. JOS Class II 1988-06-30
K881988 3M WOUND CONTACT MATERIAL, PRODUCT #563X 3M Company NAD Class I 1988-06-27
K880484 SURGICAL GARMENTS Greene International Corp. FYC Class II 1988-06-27
K881788 KTP/532(TM) SURGICAL LASER Laserscope GEX Class II 1988-06-27
K882283 BOUFFANT CAP A Plus International, Inc. FYF Class I 1988-06-23
K882269 STORZ DIAGNOSTIC MICROSCOPE SYSTEM Storz Instrument Co. EPT Class I 1988-06-23
K882333 FLOOR LIGHT Commercial Products & Engineering Co. FSS Class II 1988-06-23
K882280 COVER, SHOE OPERATING ROOM A Plus International, Inc. FXP Class I 1988-06-23
K880383 KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON Kimberly-Clark Corp. FYA Class II 1988-06-23
K880384 KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT Kimberly-Clark Corp. BWP Class I 1988-06-23
K880382 KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN Kimberly-Clark Corp. FYA Class II 1988-06-23
K882282 SUIT, SURGICAL A Plus International, Inc. FXO Class I 1988-06-23
K882284 SURGEONS CAP A Plus International, Inc. FYF Class I 1988-06-23
K882349 MALLET, SURGICAL Treace Medical, Inc. HXL Class I 1988-06-23
K880386 KIMBERLY-CLARK PROTECTIVE SLEEVE Kimberly-Clark Corp. FYA Class II 1988-06-23
K882281 GOWN, ISOLATION, SURGICAL (FYC) A Plus International, Inc. FYC Class II 1988-06-23
K882160 COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR Coherent Medical Lasers GEX Class II 1988-06-22
K882331 SHAW SUN SYSTEMS MODEL 1600 Shaw Sun Systems LEJ Class II 1988-06-22
K881403 MCCAIN MONOPOLAR & BIPOLAR CAUTERY Walter Lorenz Surgical, Inc. GEI Class II 1988-06-22
K881763 COLORADO NEEDLE ELECTRODE Colorado Biomedical, Inc. JOS Class II 1988-06-20
K881687 CAVITRON ELECTROSURGICAL MODULE (CEM) AND PAK Cavitron Surgical Systems GEI Class II 1988-06-20

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