meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
39
Latest Decision
1997-03-10

Clearances · page 95 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K970286 PRESBYTERIAN LINEN SERVICES SURGICAL PACKS Medline Industries, Inc. LRO Class II 1997-03-10
K961269 PULSEMASTER American Dental Technologies, Inc. GEX Class II 1997-03-10
K965146 FLAT CLOSED WOUND DRAIN WITH TROCAR Axiom Medical, Inc. GBX Class I 1997-03-10
K965043 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE Minnesota Mining and Mfg. Co. FXX Class II 1997-03-10
K962446 SHARPLAN RUBY LASER SYSTEM Sharplan Lasers, Inc. GEX Class II 1997-03-07
K964980 ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM Maxxim Medical KGO Class I 1997-03-06
K964962 SENTURA SURGICAL GLOVES Maxxim Medical KGO Class I 1997-03-06
K964997 S-SCORT (2500) Sscor BTA Class II 1997-03-05
K963947 EPILASER NORMAL MODE RUBY LASER Spectrum Medical Technologies, Inc. GEX Class II 1997-03-05
K965059 CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) Thomas Industries BTA Class II 1997-03-04
K964168 PROCEDURE SPECIFIC KITS Sage Products, Inc. FXX Class II 1997-03-03
K965056 OSTEONICS SCREW HOLE PLUGS Osteonics Corp. JDK Class II 1997-02-28
K964353 CYBERLASE CO2 LASER SYSTEM Nidek, Inc. GEX Class II 1997-02-28
K970023 MEDNEXT SURGICAL BUR Mednext, Inc. HWE Class I 1997-02-28
K970040 SPINE-TECH BONE HARVESTER Spine-Tech, Inc. HWE Class I 1997-02-28
K965241 BIPOLAR SUCTION COAGULATOR Kirwan Surgical Products, Inc. GEI Class II 1997-02-28
K962666 BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN Bemiss-Jason Corp., Triad Medical Div. FYA Class II 1997-02-27
K964736 BERGEN 610 BIPOLAR COAGULATOR Bergen Mfg. GEI Class II 1997-02-27
K970039 ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) Medtrex, Inc. GEI Class II 1997-02-26
K965243 ENDOCARE ELECTROSURGICAL ELECTRODE Endocare, Inc. GEI Class II 1997-02-25
K964364 DISPOSABLE APRON Instrument Makar, Inc. LYU Class I 1997-02-25
K963970 ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM Endocare, Inc. GEH Class II 1997-02-25
K963568 MASK SURGICAL The Innovative Approach, Corp. FXX Class II 1997-02-25
K964142 MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS Medline Industries, Inc. KKX Class II 1997-02-25
K964935 SUTURE LOCK Smith & Nephew Endoscopy, Inc. KGS Class I 1997-02-25
K963081 INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS Indigo Medical, Inc. GEX Class II 1997-02-21
K964760 DORNIER MEDILAS FIBER TOME LASER Dornier Medtech America, Inc. GEX Class II 1997-02-19
K964486 ACCUCURE 3000 Lasermed, Inc. GEX Class II 1997-02-18
K964857 RAPISEAL PATCH Fusion Medical Technologies, Inc. FTL Class II 1997-02-18
K970066 UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE Unimed Surgical Products, Inc. GEI Class II 1997-02-18
K964358 AMSEAL SURGICAL FACE MASK American Seal Co. FXX Class II 1997-02-14
K970187 RUNYON LARGE VOLUME PARACENTESIS KIT Gi Supply LRO Class II 1997-02-14
K965201 O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. LRO Class II 1997-02-14
K964684 SOFTOUCH Sahar Technologies, Inc. GEX Class II 1997-02-14
K965086 CYGNUS ELECTROSURGICAL TIP CLEANER Madison Polymeric Engineering GEI Class II 1997-02-14
K964827 PROD. NO. 01-132 - SUTURE REMOVAL KIT Continental Medical Laboratories, Inc. MCZ Class I 1997-02-14
K970186 GI SUPPLY PARACENTESIS PUMP Gi Supply BTA Class II 1997-02-14
K963940 EXETER MESH Howmedica, Inc. JDJ Class II 1997-02-13
K964846 IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING Implantech Associates, Inc. MDA Class I 1997-02-12
K963683 TRU-PULSE LASER (MODIFIED) Tissue Technologies, Inc. GEX Class II 1997-02-12
K965162 LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. Lukens Medical Corp. GAM Class II 1997-02-12
K935706 EPI 2 Universal H.R. System, Inc. KCX Class I 1997-02-11
K964520 PARASCAN SCANNING DEVICE Laserscope GEX Class II 1997-02-10
K964722 DELTA N95 RESPIRATOR Racal Filter Technologies, Inc. FXX Class II 1997-02-07
K964723 RACAL N95 RESIRATOR Racal Filter Technologies, Inc. FXX Class II 1997-02-07
K964497 CERALAS DIODE LASER SYSTEM (CERALAS D15) Ceram Optec, Inc. GEX Class II 1997-02-06
K965038 GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE W. L. Gore & Associates, Inc. FTL Class II 1997-02-06
K965007 ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES Oratec Interventions, Inc. GEI Class II 1997-02-06
K963765 STRYKER STRYKEFLOW ELECTROCAUTERY PROBES Stryker Endoscopy GEI Class II 1997-01-31
K962813 DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES Maxxim Medical KGO Class I 1997-01-30
K954674 P1OP2B OR P1O92T Kay Borch A/S FYA Class II 1997-01-30
K962288 COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER Pinnacle Products, Inc. MMP Class II 1997-01-30
K965061 VIDAMED MODEDL 7600 RF GENERATOR Vidamed, Inc. GEI Class II 1997-01-28
K962654 COMPLEAT SURGICAL MASK Carl Parker Associates, Inc. FXX Class II 1997-01-27
K961560 ECLIPSE 2000 Cardiogenes GEX Class II 1997-01-27
K963675 THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE Micro-Medical Devices, Inc. KKX Class II 1997-01-27
K964761 S.A.M. FACIAL IMPLANT W/INTRODUCER W. L. Gore & Associates, Inc. FTL Class II 1997-01-27
K965054 PENCIL Megadyne Medical Products, Inc. GEI Class II 1997-01-24
K964470 APPLIED MEDICAL CLIP APPLIER Applied Medical Resources FZP Class II 1997-01-22
K963339 COHERENT ULTRAPULSE CO2 SURGICAL LASERS Coherent Medical Group GEX Class II 1997-01-22
K964921 BASIC BIOPSY TRAY. DISPOSABLE, STERILE Trinity Laboratories, Inc. LRO Class II 1997-01-22
K962632 OMNIPULSE/OMNIPULSE-MAX Trimedyne, Inc. GEX Class II 1997-01-16
K963930 CTS MIDCAB/SVH BIPOLAR SCISSORS Cardiothoracic Systems, Inc. GEI Class II 1997-01-16
K964581 SOFSILK United States Surgical, A Division of Tyco Healthc GAP Class II 1997-01-16
K962144 PHOENIX ETE TISSUE EXTENSION SYSTEM Phoenix Biomedical Corp. MKY Class I 1997-01-14
K962902 FOTONA SKINLIGHT LASER SYSTEM Medical Laser Solutions GEX Class II 1997-01-10
K963506 TENET RADIOLUCENT HAND TABLE Tenet Medical Engineering FQO Class I 1997-01-09
K962965 LIGHTSTIC MODEL 360 Rare Earth Medical, Inc. GEX Class II 1997-01-09
K964143 MINI-SYMM BIPOLAR COAGULATOR Valley Forge Scientific Corp. GEI Class II 1997-01-09
K964602 DAVIS BAYONET ELECTRODES Valleylab, Inc. GEI Class II 1997-01-09
K964076 LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES Laserscope GEX Class II 1997-01-08
K964273 DURA-BOARD ARMBOARD Allen Medical Systems, Inc. GDC Class I 1997-01-08
K962443 N95 FILTERING FACEPIECE Survivair, Inc. FXX Class II 1997-01-03
K960999 ISOLATION GOWN Copioumed Intl., Inc. FYC Class II 1996-12-30
K961342 SHOE COVER, NON-STERILE Copioumed Intl., Inc. FXP Class I 1996-12-30
K963985 UM-D3000/UM-D4000 J.J. Consulting Services, Inc. GEI Class II 1996-12-27
K960492 SI CONTROLLER MODEL SI 500 I.C Medical, Inc. BTA Class II 1996-12-23
K964031 DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM Slt-J , Ltd. GEX Class II 1996-12-23
K964125 CONVERTORS DRAPE MATERIAL Allegiance Healthcare Corp. KKX Class II 1996-12-23
K962148 VERGE VIDEOMETER Verg, Inc. FXN Class I 1996-12-20
K964443 SURGIFORM ANATOMICAL MALAR Surgical Technology Laboratories, Inc. LZK Class II 1996-12-20
K964621 A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON Alto Development Corp. GEI Class II 1996-12-20
K964072 MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED ETHICON, Inc. GAN Class II 1996-12-18
K963826 ENDOCARE CRYCARE CRYOSURGICAL SYSTEM Endocare, Inc. GEH Class II 1996-12-18
K964345 ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED ETHICON, Inc. GAM Class II 1996-12-16
K963094 CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER Cynosure, Inc. GEX Class II 1996-12-16
K963884 SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 Somnus Medical Technologies, Inc. GEI Class II 1996-12-16
K960101 ISLAND BIOSURGICAL BOLSTER Island Biosurgical, Inc. OTN Class II 1996-12-16
K964071 ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR Oratec Interventions, Inc. GEI Class II 1996-12-12
K962528 OLYMPUS MOBILE CHAIR/COUCH Keymed (Medical & Industrial Equipment), Ltd. FZK Class I 1996-12-12
K963839 CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 Cordis Corp. GCY Class I 1996-12-12
K965256 DMS-1000C DERMOABRADER Mattioli Engineering, Srl GFD Class I 1996-12-09
K963204 DMS-1000C DERMOABRADER Aesthetic Lasers, Inc. GFE Class I 1996-12-09
K964102 TENET TIBIAL FRACTURE SUPPORT Tenet Medical Engineering GBB Class I 1996-12-05
K963128 NOVAGEL SILICONE GEL SHEETING Brennen Medical, Inc. MDA Class I 1996-12-05
K964175 VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES Valleylab, Inc. GEI Class II 1996-12-05
K964121 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. JCT Class II 1996-12-04
K963558 CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR Contemporary Products, Inc. JCX Class II 1996-12-04
K964211 DAVOL PLUME FILTER (5541420) Davol Inc., Sub. C. R. Bard, Inc. GEX Class II 1996-12-02
K963715 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY Grand Medical Products LRO Class II 1996-11-27

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