meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
44
Latest Decision
1994-08-10

Clearances · page 106 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K942486 IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE Mdt Corp., Inc. FQO Class I 1994-08-10
K942335 ACI SILICATH THORACIC CATHETER American Catheter GBX Class I 1994-08-09
K942421 IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT King & Spalding LZK Class II 1994-08-08
K942420 IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT King & Spalding LZK Class II 1994-08-08
K943491 RIGHT ANGLE UROLOGIC LASER FIBER Surgitek GEX Class II 1994-08-05
K942450 ENDOPATH Ethicon Endo-Surgery, Inc. GBZ Class I 1994-08-05
K942217 PULSEJET DENTAL LASER SYSTEM Incisive Technologies, Inc. GEX Class II 1994-08-03
K943046 SKIN STAPLE REMOVAL TRAYS Sterile Concepts, Inc. MCZ Class I 1994-07-29
K942280 GORETEX SAM FACIAL IMPLANT W. L. Gore & Associates, Inc. FWP Class II 1994-07-28
K915236 IRIS G-PROBE Iriderm Div. GEX Class II 1994-07-28
K933367 GORE-TEX FACIAL IMPLANT W. L. Gore & Associates, Inc. FWP Class II 1994-07-28
K941233 GLOBAL SHOULDER O.R. DRAPE PACK Depuy, Inc. KKX Class II 1994-07-27
K925243 DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER Deknatel, Inc. GBX Class I 1994-07-27
K940436 SPONGE, LAPAROTOMY, VARIOUS SIZE Shawnee Products, Inc. GDY Class I 1994-07-26
K943231 BIOPLAR FORCEPS Cook Urological, Inc. GEI Class II 1994-07-26
K940931 ASEP(TM) PLUS SURGICAL GOWN Angelica Uniform Group, Inc. FYA Class II 1994-07-26
K930740 SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL Deknatel, Inc. GAQ Class II 1994-07-26
K930739 SUTURES POLYPROP., POLYETHELINE, NYLON & SILK Deknatel, Inc. GAP Class II 1994-07-26
K942577 SURGICAL TIP CLEANER White Knight Healthcare GEI Class II 1994-07-26
K930738 SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC Deknatel, Inc. GAL Class II 1994-07-26
K942489 ELECTROSURGICAL CUTTING & COAGULATION DEVICE Megadyne Medical Products, Inc. GEI Class II 1994-07-25
K942152 CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY Candela Laser Corp. GEX Class II 1994-07-25
K943311 ECLIPSE 3200 Cardiogenes GEX Class II 1994-07-22
K936314 ODYSSEY TAN 2000 Fitness TO Go, Inc. LEJ Class II 1994-07-22
K936249 MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES Medicon Instruments, Inc. GEI Class II 1994-07-21
K936246 MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES Medicon Instruments, Inc. GEI Class II 1994-07-21
K933465 COSMET Great Bay Medical Products, Inc. KCZ Class I 1994-07-20
K942303 TECNADYNE T-CUFF Technadyne Scientific, Inc. KCY Class I 1994-07-20
K941932 SPLASH MASK Incon Diversified Industries, Inc. LYU Class I 1994-07-19
K942896 CLAMPS AND CLIPS Surgin Surgical Instrumentation, Inc. MDM Class I 1994-07-19
K942957 O-R-EZ TIP CLEANER O-R-Ez, Inc. GEI Class II 1994-07-19
K942526 SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM Life Medical Sciences, Inc. MKY Class I 1994-07-19
K942876 IMPLANTECH DORSAL NASAL IMPLANT Implantech Associates, Inc. FZE Class II 1994-07-18
K942699 AIRFRAME SURGICAL DRAPE SUPPORT Alpha Surgical, Inc. BWN Class I 1994-07-13
K942892 CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE Conmedcorp GEI Class II 1994-07-13
K942043 DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E Alm Surgical Equipment, Inc. FQO Class I 1994-07-13
K942234 VISITEC PRECISE-POINT Visitec Co. GAP Class II 1994-07-12
K942583 PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT Bio-Vascular, Inc. FTL Class II 1994-07-08
K942022 FACE-IT SHIELD Onyx Medical Corp. LYU Class I 1994-07-08
K942915 ELECTROSURGICAL LAPAROSCOPIC INSTRUMENT Morgan Medical Co. GEI Class II 1994-07-08
K942343 LASEAWAY Q-SWITCHED RUBY LASER SYSTEM Polytec Pi, Inc. GEX Class II 1994-07-08
K933318 COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B Lumenis, Inc. GEX Class II 1994-07-08
K942315 NAVARRE PERCUTANEOUS ACCESS SET Navarre Biomedical , Ltd. KGZ Class I 1994-07-08
K931456 SURGICAL DRAPE AND GOWN TRAY Custom Medical Products, Ltd. FYA Class II 1994-07-08
K941721 EMC MODEL NO. 322870 ENDOSTAT Emc Industries GEI Class II 1994-07-06
K942607 LAPAROSCOPIC SCISSORS (DISPOSABLE) O.R. Specialties, Inc. GEI Class II 1994-07-06
K942182 MEGABEAM DENTAL FIBER Ceram Optec, Inc. GEX Class II 1994-07-06
K941770 DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES Baxter Healthcare Corp KGO Class I 1994-07-05
K930552 STERILE BARRIER SLEEVE AND COVER Patient Safety Products, Inc. MMP Class II 1994-07-05
K942439 ZEISS OPMILAS 144 SURGICAL LASERS Zeiss Humphrey System GEX Class II 1994-07-01
K942233 MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM Carl Zeiss, Inc. EPT Class I 1994-07-01
K942499 INSULATED SURGICAL ELECTRODE Springfield Surgical Instruments GEI Class II 1994-07-01
K941897 ULTRACISON HARMONIC SCALPEL HS2 BLADE Ultracision, Inc. GEI Class II 1994-07-01
K933827 BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS Bioplexus Corp. FTL Class II 1994-06-30
K941312 SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN Sharplan Lasers, Inc. GEX Class II 1994-06-30
K941972 HEMO-O-LOK King & Spalding FZP Class II 1994-06-29
K942748 INTRASITE Smith & Nephew United, Inc. NAE Class I 1994-06-29
K940239 EYE TRAY Cush Medical Products LRP Class I 1994-06-28
K942033 R&D BATTERIES, PART NOS. 5243, 5104, AND 5481 R & D Batteries, Inc. BTA Class II 1994-06-28
K940501 RE-SHARPENABLE SAW BLADES Adven Medical GFA Class I 1994-06-28
K931847 BIO-PREP CEMENT RESTRICTOR Biomedical Devices, Inc. LZN Class II 1994-06-28
K935102 SATURN LIGHT Burton Medical Products Corp. FTA Class II 1994-06-27
K940140 HM-CRYO Hill-Med, Inc. GEH Class II 1994-06-27
K932953 DERMAL GLOVES George Glove Company, Inc. LYU Class I 1994-06-24
K942553 GENESIS Burton Medical Products Corp. FTD Class II 1994-06-23
K941426 SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE Symbiosis Corp. GEI Class II 1994-06-22
K942620 FEATHER-TOUCH SINGLE-STICK DEVICE Ulster Scientific, Inc. FMK Class II 1994-06-22
K941419 DISPOSABLE SPINAL INTRODUCER SHEATH Trimedyne, Inc. GEX Class II 1994-06-21
K932883 OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM Trimedyne, Inc. GEX Class II 1994-06-21
K932632 CHAKOFF ENDOSCOPY LAPAROSCOPIC INSTRUMENTATION Stephen Chakoff, Inc. GEI Class II 1994-06-21
K936036 KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION KARL STORZ Endoscopy-America, Inc. GEI Class II 1994-06-20
K933748 SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD Bam Corp., Ltd. FXX Class II 1994-06-17
K936207 ENDO-NEEDLE INSTRUMENT Gerard Medical, Inc. GDM Class I 1994-06-16
K936304 ELECTROSURGICAL PENCIL E & M Engineering, Inc. GEI Class II 1994-06-13
K931146 SURGICAL DRAPES, MODIFICATION Amsco Sterile Recoveries, Inc. KKX Class II 1994-06-13
K942304 MICROFLEX Moeller Microsurgical, Inc. FSO Class I 1994-06-13
K942156 EPI-DERM SILICONE GEL SHEETING Biodermis Corp. MDA Class I 1994-06-13
K940616 SKYTRON ELITE 3500 TABLE Skytron, Div. the Kmw Group, Inc. GDC Class I 1994-06-13
K931145 NON-STERILE ISOLATION GOWN Amsco Sterile Recoveries, Inc. FYC Class II 1994-06-10
K931144 STERILE SURGEON'S GOWN, MODIFICATION Amsco Sterile Recoveries, Inc. FYA Class II 1994-06-10
K941150 MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES Mdt Technology For Life FQO Class I 1994-06-10
K942319 HIRSCH BIPOLAR COAGULATION FORCEPS AND ADAPTOR CABLES Berchtold Holding GmbH GEI Class II 1994-06-08
K940156 THE REEL THING Bio-Medical Devices, Inc. GBX Class I 1994-06-07
K936075 REUSABLE, HAND CONTROLLED ESP E & M Engineering, Inc. GEI Class II 1994-06-06
K940461 ALEXANTRIPTOR Servicetrends, Inc. GEX Class II 1994-06-02
K934116 WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION Boston Scientific Scimed, Inc. JCT Class II 1994-06-02
K942274 ORION SUCTION CATHETER KIT WITH STERILE SALINE Regulatory & Marketing Services, Inc. GBX Class I 1994-06-02
K940955 REFLEX EGR Ricard-Allan Medical GEI Class II 1994-06-02
K942273 ORION SUCTION CATHETER KIT WITH STERILE WATER Regulatory & Marketing Services, Inc. GBX Class I 1994-06-02
K940607 CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1994-05-31
K940636 CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1994-05-31
K941125 NOVAGEL SILICONE GEL SHEETING Brennen Medical, Inc. MDA Class I 1994-05-31
K942366 LORREX GAUZE SPONGES, X-RAY DETECTABLE Lorrex Health Products GDY Class I 1994-05-27
K940175 MEDSURG STERILE O.R. TOWELS Medsurg Industries, Inc. KKX Class II 1994-05-26
K934664 HYDRAGOWN Mallinckrodt Group, Inc. FYA Class II 1994-05-24
K942215 CONMED ELECTROSURGICAL GROUNDING PADS Conmedcorp GEI Class II 1994-05-24
K942194 QUANTUM BI-POLAR ELECTROSURGICAL CABLE Quantum Instruments Corp. GEI Class II 1994-05-23
K940707 3M SURGICAL MASK WITH FACE SHEILD 3M Company FXX Class II 1994-05-23
K941908 QUANTUM MONO-POLAR ELECTROSURGICAL CABLE Quantum Instruments Corp. GEI Class II 1994-05-23
K941909 MEGA BEAM LATERAL FIRE Hogan & Hartson GEX Class II 1994-05-23

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