meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
42
Latest Decision
1992-01-09

Clearances · page 118 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K915214 ARTHROSCOPY CAMERA DRAPE O.R. Concepts, Inc. KKX Class II 1992-01-09
K915141 712 PLASTIC SURGERY TABLE & ACCESORIES Midmark Corp. FQO Class I 1992-01-09
K911915 HEMOCLIP II Edward Weck, Inc. FZP Class II 1992-01-09
K915150 REMOVE ADHESIVE REMOVER Smith & Nephew United, Inc. KOX Class I 1992-01-09
K914910 DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE) Davol, Inc. GEI Class II 1992-01-06
K914913 GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST Ideal Medical, Inc. GDJ Class I 1991-12-31
K912813 SIRIUS Pfizer Laser Systems GEX Class II 1991-12-31
K910823 PERCUDISC(TM) SYSTEM Percudisc, Inc. GEX Class II 1991-12-30
K912781 ELECTROSHIELD Electroscope, Inc. GEI Class II 1991-12-30
K913625 ELECTROSCOPE MONITOR, EM-1 Electroscope, Inc. GEI Class II 1991-12-30
K912780 MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD Electroscope, Inc. GEI Class II 1991-12-30
K913262 AESCULAP SURGICAL ACCESSORIES Aesculap, Inc. GEY Class I 1991-12-30
K913108 TEFLON COATED ELECTRODES/ELECTRODES HANDLES Olsen Electrosurgical, Inc. GEI Class II 1991-12-23
K914396 SURGI LIGHT NON-CONTACT FIBERS Lifestream Int'L, Inc. GEX Class II 1991-12-23
K914952 MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM Trimedyne, Inc. GEX Class II 1991-12-20
K912418 SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE Micromedics, Inc. KAM Class I 1991-12-20
K914412 MASK, SURGICAL, DISPOSABLE Industries For the Blind FXX Class II 1991-12-19
K913606 CHRYS XX CO2 SURGICAL LASER SYSTEM Jamar Medical Systems GEX Class II 1991-12-19
K914758 MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE Mdt Corp., Inc. GDC Class I 1991-12-19
K914297 K.D. CHIN IMPLANT Implantech Associates, Inc. FWP Class II 1991-12-19
K891411 GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT Cook, Inc. JCT Class II 1991-12-18
K914175 MICROSURGE LASER FIBER WITH SMA CONNECTOR Microsurge, Inc. GEX Class II 1991-12-17
K915393 MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE Mdt Corp., Inc. GDC Class I 1991-12-17
K915352 LASER FIBEROPTIC DELIVERY SYSTEM Sunrise Technologies, Inc. GEX Class II 1991-12-17
K914726 ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED Ion Laser Technology GEX Class II 1991-12-17
K913678 TROCAR CATHETER Medovations, Inc. KGY Class I 1991-12-16
K914252 ASCENTEC MEDICZAL SYSTEMS LAPAROSCOPIC ELECTRODE Ascentec Medical Systems GEI Class II 1991-12-13
K913887 C02 LASER WAVEGUIDE Heraeus Lasersonics, Inc. GEX Class II 1991-12-09
K914029 ESOPHAGEAL Z-STENT Cook, Inc. ESW Class II 1991-12-09
K914089 SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG Sharplan Lasers, Inc. GEX Class II 1991-12-06
K914016 ZARA ZONE IV MALAR IMPLANT Byron Medical LZK Class II 1991-12-05
K914779 ALGINATE FIBER Adri/Technam NAC Class I 1991-12-04
K914449 GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE W. L. Gore & Associates, Inc. FTL Class II 1991-12-04
K914937 STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES Kerma Medical Products, Inc. NAB Class I 1991-12-04
K914071 MULTIPLE BURN DRESSING Kerma Medical Products, Inc. NAB Class I 1991-12-04
K914842 GAUZE BANDAGE ROLL Cal West Trading Co. NAB Class I 1991-12-04
K914575 SORBSAN TOPICAL WOUND DRESSING (MODIFIED) Dow B. Hickam, Inc. NAC Class I 1991-12-04
K913779 BANDAGE ROLL, GAUZE Keilei Intl., Inc. NAB Class I 1991-12-04
K914431 ABSORBENT FIBER Ulti-Med Intl., Inc. NAB Class I 1991-12-04
K913185 STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT Internacional Farmaceutica, S.A. DE C.V. GAQ Class II 1991-12-04
K914423 OPTIFIBER Minimal Invasive Therapy and Diagnostics, Inc. GEX Class II 1991-12-02
K914077 REPEL(TM) LITE CUT RESISTANT GLOVE LINERS Depuy-Raynham LYU Class I 1991-12-02
K914369 QUALTEX MAGNETIC INSTRUMENT DRAPE Deroyal Industries, Inc. KKX Class II 1991-12-02
K914177 HYDRODISECTOR Spiess Design, Inc. JCX Class II 1991-11-29
K914082 SUAN FLAT DISSECTOR SPONGES Icn Pharmaceuticals, Inc. GDY Class I 1991-11-27
K913536 PRC AUTOPSY DEVICE Pennstate KKX Class II 1991-11-22
K914015 CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP Pilling Co. GBZ Class I 1991-11-21
K913758 KTP/532 AND KTP/YAG Laserscope GEX Class II 1991-11-20
K913794 SIMPEX INC. SURGICAL DRESSING Simpex, Inc. GDY Class I 1991-11-20
K913430 IRIS OCULIGHT(R) SLX Iriderm Div. GEX Class II 1991-11-15
K913629 JOHNSON AND JOHNSON POWER SYSTEM Johnson & Johnson Orthopaedics, Inc. HSZ Class I 1991-11-13
K914076 MDT/CASTLE 2000 SURGICAL LIGHTS Mdt Corp., Inc. FSY Class II 1991-11-13
K914677 MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG Sunrise Technologies, Inc. GEX Class II 1991-11-08
K910978 ACCU-BEAM LAPAROSCOPIC SYSTEM Tti Medical GEI Class II 1991-11-07
K914568 MODEL DLASER 1000 ND;YAG LASER SYSTEM Sunrise Technologies, Inc. GEX Class II 1991-11-07
K913559 OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR Osteo AG HSZ Class I 1991-11-07
K913558 RELIABLE CONE STYLE FACE MASK Anago, Inc. FXX Class II 1991-11-07
K911926 POLARIS, OPHTHALMOLOGY Pfizer Laser Systems GEX Class II 1991-11-07
K914066 ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS Laparomed Corp. GEI Class II 1991-11-07
K912730 ROCKET SURGICAL SKIN MARKING PEN West Texas Lighthouse For the Blind FZZ Class I 1991-11-07
K913514 ELECTROSURGICAL UNIT CABLE Kirwan Surgical Products, Inc. GEI Class II 1991-11-05
K912612 SMOKE/ODOR EVACUATOR #757 Olsen Electrosurgical, Inc. FYD Class II 1991-11-01
K913136 LASER ENDOSCOPE DISC DECOMPRESSION KITS Medical Laser, Inc. LRO Class II 1991-11-01
K913369 MICRO-AIRE MODEL 2060 Micro Surgical Instruments Corp. GEY Class I 1991-11-01
K910530 CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY Heraeus Lasersonics, Inc. GEX Class II 1991-10-31
K913815 AUTOMATED BIOPSY DEVICE, MODIFICATION Hart Enterprises, Inc. DWO Class I 1991-10-30
K913992 ASPIRATION/INJECTION NEEDLE Northgate Technologies, Inc. GAA Class I 1991-10-30
K913760 PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT Psoralite Corp. FTC Class II 1991-10-28
K912987 CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE Douglas James Donaldson Compliance Services GEX Class II 1991-10-28
K911354 STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES Internacional Farmaceutica, S.A. DE C.V. GAL Class II 1991-10-25
K914365 DEXON DISSECTING SPONGE Davis & Geck, Inc. GAK Class II 1991-10-23
K914207 CLEARSITE(R) STERILE WOUND CARE DRESSING Ndm Acquisition Corp. NAE Class I 1991-10-23
K913964 MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS Marlo Surgical Technology HTD Class I 1991-10-23
K913465 NIDEK MODELS AC-2100 & 2200 Nidek, Inc. GEX Class II 1991-10-21
K913266 MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS Micro Surgical Instruments Corp. GEY Class I 1991-10-21
K913569 COMPAC A, ELITE A, ELITE A PLUS, SURGICA A Hgm Medical Laser Systems, Inc. GEX Class II 1991-10-17
K913802 AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 1991-10-17
K914400 MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS Valleylab, Inc. GEI Class II 1991-10-17
K913761 3-D ACCUSCAN FACIAL IMPLANTS Implantech Associates, Inc. FWP Class II 1991-10-17
K914130 AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES United States Surgical, A Division of Tyco Healthc GDW Class II 1991-10-17
K913832 AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 1991-10-17
K913191 DORNIER LASER LITHOTRIPTER IMPACT Dornier Medtech America, Inc. GEX Class II 1991-10-16
K912063 POLARIS, ORAL INDICATION Pfizer Laser Systems GEX Class II 1991-10-16
K911983 WIZARD STERILIZED ELECTROEPILATION NEEDLE Skin Deep, Inc. KCW Class I 1991-10-15
K910341 POLARIS Pfizer Laser Systems GEX Class II 1991-10-11
K910687 GUARDIAN GEL, SURGEON'S GLOVING CREAM Guardian Angel Products, Inc. KGQ Class I 1991-10-11
K913506 CONVERTORS SAFECARE GOWN & DRAPE MATERIAL Baxter Healthcare Corp KKX Class II 1991-10-11
K912703 OPTICA 60 ND;YAG SURGICAL LASER SYSTEM Xintec Corporation GEX Class II 1991-10-11
K911925 POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU Pfizer Laser Systems GEX Class II 1991-10-11
K914083 ICAN K DISSECTOR SPONGES Icn Pharmaceuticals, Inc. GDY Class I 1991-10-09
K914086 ICAN CYLINDRICAL SPONGES Icn Pharmaceuticals, Inc. GDX Class I 1991-10-09
K913382 MEGA PARACENTESIS KIT Mega Medical, Inc. KKX Class II 1991-10-08
K913127 COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR Coherent Medical Group GEX Class II 1991-10-08
K913733 STERILE CHEST TUBE Vascular Products, Inc. GBW Class I 1991-10-08
K913109 LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK Trimedyne, Inc. GEX Class II 1991-10-08
K912737 MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV Medical Armor Corp. LYU Class I 1991-10-08
K912693 POST OPERATIVE SPONGE Ulti-Med Intl., Inc. NAB Class I 1991-10-04
K913628 DISPOSABLE SHOE COVER Gem Nonwovews, Inc. FXP Class I 1991-10-04
K912692 CONFORMING BANDAGE Ulti-Med Intl., Inc. NAB Class I 1991-10-04
K912637 LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE Dexide, Inc. GEI Class II 1991-10-04

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