meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
28
Latest Decision
1998-12-11

Clearances · page 89 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983200 INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX Ximed/Prosure/Injectx GAA Class I 1998-12-11
K983463 SURECAUT DIAMOND LASER KNIFE Clinicon Corp. GEX Class II 1998-12-11
K981922 LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI Microaire Surgical Instruments, Inc. QPB Class II 1998-12-10
K981746 CELL ROBOTICS' LASETTE Cell Robotics, Inc. GEX Class II 1998-12-07
K982614 RUSCH POLYFLEX STENT KIT Rusch Intl. NYT Class II 1998-12-04
K981781 ELECTROSURGICAL UNIT Hill-Med, Inc. GEI Class II 1998-12-04
K983215 MULTIPULSE CO2 LASER Aesculap-Meditec GmbH GEX Class II 1998-12-04
K983236 BIPOLAR HF CABLE Richard Wolf Medical Instruments Corp. GEI Class II 1998-12-04
K983116 ELECTROSURGICAL INFLATABLE BASKET ELECTRODES Conway Stuart Medical, Inc. GEI Class II 1998-12-03
K982212 VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 Synergetics, Inc. GEI Class II 1998-12-02
K983871 RITA MODEL 70 ELECTROSURGICAL PROBE Rita Medical Systems GEI Class II 1998-12-01
K982059 ROTECNO 2000 SURGICAL GOWN Encompass Group, LLC FYA Class II 1998-11-30
K983240 NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES Johnson & Johnson Medical, Div. of Ethicon, Inc. KGO Class I 1998-11-30
K983108 SUTURE WELDING SYSTEM AND KIT (SWK) Axya Medical, Inc. GAW Class II 1998-11-27
K983788 AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE Aaron Medical Industries GEI Class II 1998-11-25
K982280 CRYOPRO MAXI AND CRYOPRO MINI Cortex Technology Aps GEH Class II 1998-11-25
K983963 DORNIER MEDILA H Dornier Medtech America, Inc. GEX Class II 1998-11-25
K983020 COMPACT KTP LASER Cosmos Medical Technology GEX Class II 1998-11-25
K981379 AURORA Premier Laser Systems, Inc. GEX Class II 1998-11-23
K982965 ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES Richard Wolf Medical Instruments Corp. FWF Class I 1998-11-23
K982971 ORATEC TAC-C, MONOPOLAR CAUTERY PROBE Oratec Interventions, Inc. GEI Class II 1998-11-23
K983755 NASAL DORSAL SERIES Surgical Technology Laboratories, Inc. FZE Class II 1998-11-20
K983756 SURGIFORM ANATOMICAL MALAR Surgical Technology Laboratories, Inc. LZK Class II 1998-11-20
K983754 STANDARD CHIN Surgical Technology Laboratories, Inc. FWP Class II 1998-11-20
K982941 HEM-O-LOK MODEL NUMBERS 523900, 523970 Weck Closure Systems FZP Class II 1998-11-19
K982944 HEM-O-LOCK, MODEL 523935 Weck Closure Systems FZP Class II 1998-11-19
K982854 MR COMPATIBLE LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp. GEI Class II 1998-11-10
K982575 MESH, SURGICAL, POLYMERIC United States Surgical, A Division of Tyco Healthc FTL Class II 1998-11-06
K982826 MEGA 2000 Megadyne Medical Products, Inc. GEI Class II 1998-11-06
K982748 BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 New Deantronics Taiwan , Ltd. GEI Class II 1998-11-03
K982717 SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 Somnus Medical Technologies, Inc. GEI Class II 1998-11-02
K981096 SEMPERMED SURGEONS' GLOVES - SUPREME Semperit Technische Produkte Gesellshaft KGO Class I 1998-10-29
K982082 HANDISOL WOUND HEALING National Biological Corp. FTC Class II 1998-10-28
K982693 MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS Medline Industries, Inc. FYA Class II 1998-10-28
K982984 ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS Microline Pentax, Inc. GEI Class II 1998-10-21
K983058 CERALAS D LASER SYSTEM, MODEL # CERALAS D15 Ceram Optec, Inc. GEX Class II 1998-10-21
K982548 MLT 30 LASER Medical Laser Technologies , Ltd. GEX Class II 1998-10-19
K981888 SMOKE-EVAC Bio-Medical Devices, Inc. GEI Class II 1998-10-15
K981645 TITANIUM HEMOSTATIC CLIP Vitalitec Int'L., Inc. FZP Class II 1998-10-13
K983162 PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC Bio-Vascular, Inc. FTM Class II 1998-10-09
K983211 CENTAURI Premier Laser Systems, Inc. GEX Class II 1998-10-09
K982358 HISTOFREEZER DEVICE OraSure Technologies, Inc. GEH Class II 1998-10-02
K982113 UMECO OPTIMA 694 RUBY LASER SYSTEM Umeco, Inc. GEX Class II 1998-09-30
K982763 SEARE BIOMEDICAL MALAR IMPLANTS Seare Biomedical Corp. LZK Class II 1998-09-30
K982753 SEARE BIOMEDICAL NASAL IMPLANTS Seare Biomedical Corp. FZE Class II 1998-09-30
K982752 SEARE BIOMEDICAL CHIN IMPLANTS Seare Biomedical Corp. FWP Class II 1998-09-30
K974170 DUOSTAR Mti Corp./ Electrostar S.A.-Haiti GEI Class II 1998-09-30
K982330 DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT Depuy, Inc. FTM Class II 1998-09-25
K982304 DEVILBISS SUCTION UNIT Sunrise Medical Hhg, Inc. JCX Class II 1998-09-25
K982230 LASETTE LASER SKIN PERFORATOR Cell Robotics, Inc. GEX Class II 1998-09-24
K980398 KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II Optomedic Medical Technologies , Ltd. GEX Class II 1998-09-22
K982403 BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Brennen Medical, Inc. PAG Class II 1998-09-22
K982475 SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL Tissue Technologies, Inc. FTL Class II 1998-09-22
K982063 ALM PRISMALIX (PRX) SURGICAL LIGHT Alm Surgical Equipment, Inc. FSY Class II 1998-09-22
K982176 KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR Kirwan Surgical Products, Inc. GEI Class II 1998-09-18
K981570 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD Aaron Medical Industries GEI Class II 1998-09-14
K981143 DILKES LASER/SUCTION CANNULAE Exmoor Plastics , Ltd. GEX Class II 1998-09-14
K982743 DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH New Deantronics Taiwan , Ltd. GEI Class II 1998-09-14
K982742 DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH New Deantronics Taiwan , Ltd. GEI Class II 1998-09-14
K982827 DERMA K ER:YAG/CO2 LASER Esc Medical Systems, Inc. GEX Class II 1998-09-14
K982884 DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH New Deantronics, Ltd. GEI Class II 1998-09-14
K982629 DORNIER MEDILAS D Dornier Surgical Products, Inc. GEX Class II 1998-09-14
K982746 MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 New Deantronics Taiwan , Ltd. GEI Class II 1998-09-14
K982749 MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 New Deantronics Taiwan , Ltd. GEI Class II 1998-09-14
K982744 DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH New Deantronics Taiwan , Ltd. GEI Class II 1998-09-11
K983034 CYNOSURE CO3 ER:YAG LASER Cynosure, Inc. GEX Class II 1998-09-10
K982397 VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM Angiolaz, Inc. FWF Class I 1998-09-10
K982589 SURGEON'S GLOVE Shiva Medicare , Ltd. KGO Class I 1998-09-10
K982705 MIDAS TOUCH BIPOLAR FORCEPS Iti Medical Technologies, Inc. GEI Class II 1998-09-08
K982439 PROXIDERM, MODELS TN 460, TN 90 460, BK 460 Progressive Surgical Products, Inc. MKY Class I 1998-09-08
K982031 OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE Iridex Corp GEX Class II 1998-09-08
K982055 ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 Cryomedical Sciences, Inc. GEH Class II 1998-09-08
K982042 ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 Island Biosurgical, Inc. OTN Class II 1998-09-08
K981981 ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19 Boston Scientific Corp GEI Class II 1998-09-03
K982613 OMNI PRO LATEX SURGICAL GLOVE, POWDERED Omnigrace (Thailand) , Ltd. KGO Class I 1998-09-02
K981952 COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER Instruments For Medicine and Diagnostics GEX Class II 1998-09-01
K982677 UNI/MONOPOLAR HF CABLE Richard Wolf Medical Instruments Corp. GEI Class II 1998-08-31
K981916 LIGASURE VESSEL SEALING SYSTEM Valleylab, Inc. GEI Class II 1998-08-28
K980559 PEGASUS ND:YAG LASER SYSTEM Premier Laser Systems, Inc. GEX Class II 1998-08-24
K982369 CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS Allegiance Healthcare Corp. FYC Class II 1998-08-24
K982409 VES 1501-M Angiolaz, Inc. FWF Class I 1998-08-21
K981870 VISAGE COSMETIC SURGERY SYSTEM Arthrocare Corp. GEI Class II 1998-08-20
K980588 CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 Clarus Medical Systems, Inc. GAD Class I 1998-08-18
K981962 CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE Cuda Products Co. FSS Class II 1998-08-18
K981703 KSEA UNIMAT 45 Karl Storz Endoscopy BTA Class II 1998-08-12
K981823 OPERATING ROOM TOWELS Baldur Systems Corp. KKX Class II 1998-08-11
K982586 POWDER FREE SURGEONS GLOVE Shiva Medicare , Ltd. KGO Class I 1998-08-11
K982313 HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS Weck Closure Systems FZP Class II 1998-08-10
K982130 RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 New Deantronics, Ltd. GEI Class II 1998-08-07
K982295 NIDEK LIGHTSCAN Nidek, Inc. GEX Class II 1998-08-06
K982036 SILON SCAR STRIPS Bio Med Sciences, Inc. MDA Class I 1998-08-06
K981919 BISSINGER CABLES, CAT. NO. 801000XX Guenter Bissinger Medizintechnik GmbH GEI Class II 1998-08-06
K982051 KELOCATE SHEETING Allied Biomedical Corp. MDA Class I 1998-08-05
K981908 UM-150A Umeco Union Medical Engineering GEI Class II 1998-08-05
K981756 SHELHIGH NO-REACT PNEUMOPLEDGETS Shelhigh, Inc. FTL Class II 1998-08-05
K982309 SMOKE EVACUATION ATTACHMENT 130XXX TBD Conmedcorp GEI Class II 1998-08-05
K981819 ANGIOLAZ VES-1CAM Angiolaz, Inc. FWF Class I 1998-08-04
K981627 PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) Xintec Corporation GEX Class II 1998-07-31
K981589 ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES Conway Stuart Medical, Inc. GEI Class II 1998-07-30
K981821 VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR Angiolaz, Inc. FSS Class II 1998-07-29

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