meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
31
Latest Decision
1999-04-16

Clearances · page 88 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K991034 CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. FYA Class II 1999-04-16
K990458 STRAUMANN EXTRAORAL IMPLANT SYSTEM Straumann USA KCZ Class I 1999-04-16
K984213 NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS Capital Marketing Technologies, Inc. MDA Class I 1999-04-14
K990417 DERMACOOL Optomed Corp. GEX Class II 1999-04-14
K990395 BARRIER SURGICAL GOWNS Johnson & Johnson Medical, Div. of Ethicon, Inc. FYA Class II 1999-04-13
K990861 WOUND DRESSING/ABD PAD, MODEL #10810 Hospital Specialty Co. NAD Class I 1999-04-12
K984337 ELASTYLON POWDER-FREE SURGICAL GLOVE Eci Medical Technologies, Inc. KGO Class I 1999-04-09
K984389 TOP WHOLESOME FACE MASK Top Wholesome Enterprise Co., Ltd. FXX Class II 1999-04-09
K982940 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM Star Medical Technologies, Inc. GEX Class II 1999-04-08
K984422 STERILE BACK SURGICAL GOWN WITH HAND TOWEL Medical Sterilization, Inc. FYA Class II 1999-04-02
K990952 NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES United States Surgical, A Division of Tyco Healthc GAT Class II 1999-04-01
K990174 ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV Fisma, Inc. GEX Class II 1999-04-01
K983524 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) Lares Research, Inc. GEX Class II 1999-04-01
K990951 MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1999-04-01
K990851 INDIGO LASEROPTIC TREATMENT SYSTEM Indigo Medical, Inc. GEX Class II 1999-03-30
K990062 SAPHLIFT Genzyme Surgical Product (Genzyme Biosurgery) MDM Class I 1999-03-30
K984611 DRAGER SOLA SERIES, MODELS 1000/700/500/300 Drager Medizintechnik GmbH FSY Class II 1999-03-29
K984591 DORNIER MEDILAS H/2 Dornier Surgical Products, Inc. GEX Class II 1999-03-26
K983986 CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR Conway Stuart Medical, Inc. GEI Class II 1999-03-23
K990780 NUVOLASE 532 CUTANEOUS LASER SYSTEM American Laser Medical GEX Class II 1999-03-22
K990090 DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE Aesculap, Inc. GAR Class II 1999-03-22
K990725 NUVOLASE 532 LASER SYSTEM American Laser Corp. GEX Class II 1999-03-22
K982816 VNUS CLOSURE SYSTEM Vnus Medical Technologies, Inc. GEI Class II 1999-03-17
K990146 SURGITRON Ellman Intl., Inc. GEI Class II 1999-03-17
K990089 SILKAM NONABSORBABLE SILK SURGICAL SUTURE Aesculap, Inc. GAP Class II 1999-03-15
K980840 LOKKI DT Hillard W. Welch GEX Class II 1999-03-15
K984018 HEMOSLEEVE, MODEL 4.0MM, 5.5MM Surgical Laser Technologies, Inc. GEI Class II 1999-03-15
K983882 MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 Micro-Medical Devices, Inc. HXR Class I 1999-03-15
K982600 PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) Wembley Rubber Products (M) Sdn Bhd KGO Class I 1999-03-12
K984552 COOL-TIP RF SYSTEM Radionics, Inc. GEI Class II 1999-03-05
K984424 AURA DYE LASER SYSTEM (ADLS) Laserscope GEX Class II 1999-03-05
K984352 AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR Aaron Medical Industries GEI Class II 1999-03-04
K982980 LIGHTSHEER LONG PULSE RUBY LASER Palomar Medical Products, Inc. GEX Class II 1999-03-04
K981947 STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) Boston Medical Corp. KGO Class I 1999-03-03
K984550 PRE-THREADED ENDOBUTTON Smith & Nephew, Inc. GAT Class II 1999-03-01
K983318 FIXATION SYSTEM General Surgical Innovations GDW Class II 1999-03-01
K990014 DIOSCAN Diomed, Inc. GEX Class II 1999-02-26
K984559 ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) Ansell Perry KGO Class I 1999-02-26
K984558 DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) Ansell Perry KGO Class I 1999-02-26
K984363 XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM Xomed, Inc. BTA Class II 1999-02-26
K973865 BIRTCHER UV LAMP Medfaxx, Inc. MXG Class II 1999-02-26
K984417 BIPOLAR GRASPING FORCEPS BIQ+ Olympus America, Inc. GEI Class II 1999-02-24
K984220 MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. FTL Class II 1999-02-23
K983208 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR Wallach Surgical Devices, Inc. GEI Class II 1999-02-22
K984339 MEDART 455 SCANNER SYSTEM Del Mar Technologies, Inc. GEX Class II 1999-02-18
K982371 MEDCO ASPIRATOR IV Medco Mfg. BTA Class II 1999-02-12
K984115 SCAREASE & SCAREASE ADHESIVE GEL Scarease, Inc. MDA Class I 1999-02-12
K990043 SMOOTHLASE ALEXANDRITE LASER SYSTEM Leisegang Medical, Inc. GEX Class II 1999-02-11
K983400 AUTO SUTURE SITE MARKER CLIP United States Surgical, A Division of Tyco Healthc GDW Class II 1999-02-10
K984276 DISPOSABLE ELECTROSURGERY GROUNDING PAD E & M Engineering, Inc. GEI Class II 1999-02-10
K983054 MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER Continuum Biomedical, Inc. GEX Class II 1999-02-10
K984239 SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z Aaron Medical Industries GEI Class II 1999-02-10
K990088 SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE Aesculap, Inc. GAT Class II 1999-02-10
K984236 AARON ESU FOOT-CONTROL ADAPTER #A1205A Aaron Medical Industries GEI Class II 1999-02-10
K984349 DORNIER MEDILAS R Dornier GEX Class II 1999-02-04
K982472 GENICON TROCAR Genicon, LC GEA Class I 1999-02-04
K982119 DIODE LASER Esc Medical Systems , Ltd. GEX Class II 1999-02-04
K984601 CANDELA GENTLELASE II DERMATOLOGICAL LASER Candela Corp. GEX Class II 1999-02-04
K983950 CERALAS DIODE LASER SYSTEM (MODEL H) Ceram Optec, Inc. GEX Class II 1999-02-03
K981949 NUMOBAG Numotech, Inc. KPJ Class II 1999-02-03
K984124 AESCULAP XENON LIGHT SOURCE Aesculap, Inc. FSS Class II 1999-02-01
K984275 THE GOLDEN TIP ELECTRO-SURGICAL PROBE Amada Surgical GEI Class II 1999-02-01
K983868 OPMI TWINER SURGICAL MICROSCOPE Carl Zeiss, Inc. GEX Class II 1999-01-29
K984448 BIRCOLL BALLOON DISSECTOR Wells Johnson Co. FZW Class I 1999-01-28
K983852 BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 Geiger Medical Technologies, Inc. GEI Class II 1999-01-28
K982506 VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM Cryosurgery, Inc. GEH Class II 1999-01-27
K983100 KAVO KEY LASER 1242 Kavo America GEX Class II 1999-01-27
K983782 ELECTROSURGICAL DISPERSIVE ELECTRODE Conmedcorp GEI Class II 1999-01-25
K983743 BISURE LAPAROSCOPIC BIPOLAR FORCEPS Valleylab, Inc. GEI Class II 1999-01-21
K983647 ECHO-COAT ULTRASOUND NEEDLES Sts Biopolymers MJG Class I 1999-01-20
K982532 PARIETEX Cogent FTL Class II 1999-01-20
K984517 CYNOSURE ERASURE LASER Cynosure, Inc. GEX Class II 1999-01-20
K983673 LASETTE Cell Robotics, Inc. GEX Class II 1999-01-15
K982058 ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN Encompass Group, LLC FYA Class II 1999-01-14
K984066 OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM Omni Intl., Inc. KGO Class I 1999-01-13
K982957 SENSIFLEX POWDERFREE SURGEON'S GLOVE Terang Nusa Sdn Bhd KGO Class I 1999-01-13
K983654 CYBER-LASE 2000 CURING AND WHITENING LASER Ics of North America, Inc. GEX Class II 1999-01-12
K984064 OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE Omni Intl., Inc. KGO Class I 1999-01-08
K982754 EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) A.Stein - Regulatory Affairs Consulting FWF Class I 1999-01-08
K983962 ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES Cardinal Health,Medical Products and Services KGO Class I 1999-01-08
K983552 BASIC, MEDIAN, DOMINANT, AND VARIO Medela, Inc. BTA Class II 1999-01-07
K972335 CLEANCUT Medquest Products, Inc. GEI Class II 1999-01-07
K984197 FLUOROTEX SURGICAL MESH Bridger Biomed, Inc. FTL Class II 1999-01-07
K984438 MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE United States Surgical, A Division of Tyco Healthc FZP Class II 1999-01-07
K984068 FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS Schneider (Europe) GmbH ESW Class II 1999-01-07
K983977 LIGHT AGE EPICARE ALEXANDRITE LASER Light Age, Inc. GEX Class II 1999-01-07
K983761 AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 Aaron Medical Industries GEI Class II 1998-12-30
K982142 MOUNTABLE ENDOSCOPIC KNIFE A.M. Surgical, Inc. EMF Class I 1998-12-30
K983965 CO2 LASER COUPLER L.A.S.E.R., Inc. GEX Class II 1998-12-22
K983766 SYNTHES SYNMESH Synthes (Usa) EZX Class II 1998-12-18
K983536 PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS Ethicon Endo-Surgery, Inc. GDW Class II 1998-12-18
K983297 MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE Medtronic Instent, Inc. ESW Class II 1998-12-18
K984110 LASERSCOPE COOLSPOT Laserscope GEX Class II 1998-12-18
K984185 MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY Oratec Interventions, Inc. GEI Class II 1998-12-16
K982316 LASEAWAY ALEXANDRITE LASER SYSTEM Silver Creek, Inc. GEX Class II 1998-12-16
K983543 ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM Argus Photonics Group GEX Class II 1998-12-16
K980475 UNIPULSE CO2 SURGICAL LASER SYSTEM Nidek, Inc. GEX Class II 1998-12-16
K983277 LIGHTSOURCE OR ILLUMINATOR MODEL I-100 Cuda Products Co. HBI Class II 1998-12-16
K983489 ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) Ansell Perry KGO Class I 1998-12-14
K982694 MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES Medline Industries, Inc. FYA Class II 1998-12-14

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