meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
37
Latest Decision
1994-05-20

Clearances · page 107 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K933902 MOBLVAC III Aeros Instruments, Inc. BTA Class II 1994-05-20
K930666 REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY Snowden-Pencer GEI Class II 1994-05-19
K941356 MICROFLOW IRRIGATION SYSTEM Jedmed Instrument Co. GBQ Class I 1994-05-19
K941846 BONE MARROW BIOPSY TRAY Kormed, Inc. LRO Class II 1994-05-18
K941527 MODEL 2300 GENERAL PURPOSE SUCTION PUMP Product & Educational Services JCX Class II 1994-05-18
K941525 MODEL 2200 THORACIC SUCTION PUMP Product & Educational Services JCX Class II 1994-05-18
K941526 MODEL 2000 MILD INTERMITTENT SUCTION PUMP Product & Educational Services JCX Class II 1994-05-18
K941578 STATVAC PORTABLE SUCTION UNIT Laerdal California, Inc. BTA Class II 1994-05-18
K936109 SHARPLAN MODEL 1120 CO2 SURGICAL LASER Sharplan Lasers, Inc. GEX Class II 1994-05-17
K935563 SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES Sharplan Lasers, Inc. GEX Class II 1994-05-17
K934211 CYTOCARE DIODE LASER SYSTEM Cytocare, Inc. GEX Class II 1994-05-17
K941524 MODEL 2100 MILD INTERMITTENT SUCTION PUMP Product & Educational Services JCX Class II 1994-05-17
K942183 E2550 REUSABLE HANDSWITCHING PENCIL Valleylab, Inc. GEI Class II 1994-05-17
K942002 RETRACTOR Automated Medical Products Corp. GAD Class I 1994-05-17
K935970 FLOWGUN ELECTROCAUTERY PROBE HANDLE O.R. Concepts, Inc. GEI Class II 1994-05-16
K940218 SURESOFT SURGICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1994-05-16
K935971 FLOWGUN ELECTROCAUTERY PROBES O.R. Concepts, Inc. GEI Class II 1994-05-16
K940274 NYLON LINER GLOVES Wells Lamont Corp. LYU Class I 1994-05-12
K941344 LAP SPONGE PRODUCT LINE Cush Medical Products GDY Class I 1994-05-12
K941302 STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE Cush Industries, Inc. KKX Class II 1994-05-12
K936223 PRESSURE IRRIGATING SYSTEM Level 1 Technologies, Inc. GCY Class I 1994-05-12
K933811 MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST Pitt Enterprises (Silicone) , Ltd. MDA Class I 1994-05-12
K941522 STERILE X-RAY DETECTABLE GAUZE SPONGES Cush Medical Products GDY Class I 1994-05-12
K934865 OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM Trimedyne, Inc. GEX Class II 1994-05-12
K941694 ISL QC 2000 LASER Intelligent Surgical Lasers, Inc. GEX Class II 1994-05-12
K925467 JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT J.J. Skinner, Inc. LRO Class II 1994-05-11
K941968 VALLEY MODEL E2750-T PENCIL GRIP LAPAROSCOPIC Valleylab, Inc. GEI Class II 1994-05-10
K935464 COMFIT Wembley Rubber Products (M) Sdn Bhd KGO Class I 1994-05-09
K940797 SIME SURGICAL LATEX GLOVE Sime Health, Ltd. KGO Class I 1994-05-09
K940068 STRYKER OPERATING ROOM TABLE Stryker Medical FQO Class I 1994-05-05
K931418 SURGICAL DRAPE Custom Medical Products, Ltd. KKX Class II 1994-05-05
K931455 HEAD SHEET Custom Medical Products, Ltd. KKX Class II 1994-05-05
K930815 ABDOMINAL / THORACIC PATIENT DRAPE Custom Medical Products, Ltd. KKX Class II 1994-05-05
K940552 MONOPOLAR SURGICAL INSTRUMENTS Tnco, Inc. GEI Class II 1994-05-05
K935531 OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP Puritas Health Care, Inc. GBX Class I 1994-05-05
K941019 BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING Brady Medical Products Co. NAE Class I 1994-05-04
K932834 TECNOL PCM 2000 Tecnol Medical Products, Inc. FXX Class II 1994-05-03
K940934 LIFE VAC Life Support Products, Inc. BTA Class II 1994-05-03
K940756 ISOLYSER (X-RAY DETECTABLE) Thantex Specialties, Inc. GDY Class I 1994-05-02
K934976 INSTAVAC II Aeros Instruments, Inc. BTA Class II 1994-05-02
K940755 ISOLYER (4X4, 8PLY) Isolyer Co. NAB Class I 1994-05-02
K940299 ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD Debusk Technology Corp. GEI Class II 1994-05-02
K932981 COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS Coherent Medical Group GEX Class II 1994-05-02
K931580 DISPOSABLE SURGICAL MASK (MODIFIED) Bam Corp., Ltd. FXX Class II 1994-05-02
K940763 ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) Thantex Specialties, Inc. GDY Class I 1994-05-02
K940762 ISOLYSER (18X18 X-RAY DETECTABLE) Thantex Specialties, Inc. GDY Class I 1994-05-02
K940205 PERI-STRIPS Bio-Vascular, Inc. FTM Class II 1994-05-02
K940757 ISOLYSER (4X18) X-RAY DETECTABLE Thantex Specialties, Inc. GDY Class I 1994-05-02
K932938 ELMED ESU 300 M/M AND DIGITAL Elmed, Inc. GEI Class II 1994-05-02
K931429 COOL CUT Mitab HWE Class I 1994-04-29
K932133 EYSOTEK Isotech Corp. FXX Class II 1994-04-29
K932132 EYSOTEK Isotech Corp. FXX Class II 1994-04-29
K934706 CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR Candela Laser Corp. GEX Class II 1994-04-29
K930416 SURGICAL SUTURE PACKAGE INSERTS United States Surgical, A Division of Tyco Healthc GAL Class II 1994-04-28
K940702 CONVERTORS OPTI-SORB DRAPE MATERIAL Baxter Healthcare Corp KKX Class II 1994-04-26
K912529 ERGOMED Kryoderm USA, Inc. GEH Class II 1994-04-26
K934261 ERBOKRYO CA CRYOSURGICAL SYSTEM Erbe Elektromedizin GmbH GEH Class II 1994-04-26
K935753 THE GRAFTOLOGER Neoligaments, Ltd. HWE Class I 1994-04-25
K941465 SUTURE REMOVAL KIT Clinical Resources, Inc. MCZ Class I 1994-04-22
K941399 OPERATING MICROSCOPE AA OM 10 Appasamy Associates (U.S.A.), Inc. FSO Class I 1994-04-22
K940758 COMPEL SURGICAL GOWNS Standard Textile Co., Inc. FYA Class II 1994-04-22
K933245 ULTRALINE II STERILE DISPOSABLE FIBER Heraeus Lasersonics, Inc. GEX Class II 1994-04-21
K940466 TITANIUM BIPOLAR FORCEPS Radionics, Inc. GEI Class II 1994-04-21
K935367 TAVA WIRE-DRIVER Tava Surgical Instruments HSZ Class I 1994-04-21
K941217 DUPAQUE SPONGE Dumex Medical Surgical Products, Ltd. GDY Class I 1994-04-21
K935158 KACEY DISPOSABLE GLOVE LINER K & C Medical, Inc. LYU Class I 1994-04-20
K941160 CONMED T.D.S. ELECTROSURGICAL GROUND PAD Conmedcorp GEI Class II 1994-04-19
K940936 AESCULAP ENDOSCOPIC INSTRUMENTS Aesculap, Inc. GEI Class II 1994-04-19
K940192 MIS ELECTROSURGICAL ELECTRODES National Wire & Stamping, Inc. GEI Class II 1994-04-19
K933211 D'AMICO\PEYMAN FLUTED ENDOPROBE Iriderm Div. GEX Class II 1994-04-19
K935495 PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 Perimed, Inc. GEX Class II 1994-04-18
K933933 CEBOPLANE Synvasive Technology, Inc. HTZ Class I 1994-04-15
K935381 KAPS POSITIONING ARM Andronic Devices, Ltd. FWZ Class I 1994-04-15
K941448 RETRACTOR Technovations GAD Class I 1994-04-15
K932137 FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR Tecnol Medical Products, Inc. FXX Class II 1994-04-15
K940352 STORZ N5941 SERIES MEDICAL GRADE TUBING Storz Instrument Co. GBX Class I 1994-04-14
K931042 MOORE SECURE CAP Kerma Medical Products, Inc. LYU Class I 1994-04-13
K934974 FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD Mid America Medical, Inc. FXX Class II 1994-04-13
K940219 TRIGEL- MULTIFUNCTION ELECTRODE Physiometrix, Inc. GEI Class II 1994-04-12
K932345 TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE Conmedcorp DWG Class II 1994-04-12
K932731 BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN Johnson & Johnson Medical, Inc. FYE Class I 1994-04-11
K934445 STSTORZ DP5300 AND DP9502 STERILE DRAPES Storz Instrument Co. KKX Class II 1994-04-11
K934608 BARRIER FABRIC 450 SURGICAL GOWN Johnson & Johnson Medical, Inc. FYA Class II 1994-04-11
K924101 STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE Baxter Healthcare Corp KKX Class II 1994-04-11
K934209 SLT REFLECTING PROBE Surgical Laser Technologies, Inc. GEX Class II 1994-04-08
K930573 SYNVASIVE CERAMIC SUTTING BLOCK Synvasive Technology, Inc. LXI Class I 1994-04-07
K935225 MITEK MODULAR DRILL BIT Mitek Surgical Products, Inc. GFG Class I 1994-04-07
K933362 SHARPLAN CO2 SURGICAL LASER Laser Industries , Ltd. GEX Class II 1994-04-07
K935723 SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD) Cabot Safety Corp. LYU Class I 1994-04-06
K933337 R AND D BATTERY REPLACEMENT R & D Batteries, Inc. KIJ Class I 1994-04-05
K940753 TAN AMERICA SUN UP Tan America LEJ Class II 1994-04-05
K935218 SCHUCO-VAC MODEL 178 Schuco, Inc. JCX Class II 1994-04-05
K923162 TBC TRAUMA SUIT PROTECTIVE GOWN Tbc, Inc. FYC Class II 1994-04-04
K925583 JOBSKIN CONTINUING CARE Jobst Institute, Inc. MDA Class I 1994-04-04
K935490 ELECTROSURGICAL DEVICE, MODEL 26-2500 Cameron-Miller, Inc. GEI Class II 1994-04-01
K935815 ERBOTOM ICC 50 Erbe USA, Inc. GEI Class II 1994-03-31
K933324 SKIN BIOPSY DEVICE Nhr, Inc. MJG Class I 1994-03-31
K936308 ENDEX ENDOSCOPIC POSITIONING SYSTEM Andronic Devices, Ltd. FQO Class I 1994-03-31
K936255 CUSTOM CV PACK Associated Medical KDD Class I 1994-03-31
K930852 OLYMPUS SUCTION PUMP MODEL KV-4 Keymed (Medical & Industrial Equipment), Ltd. JCX Class II 1994-03-31

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