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
1984-04-23

Clearances · page 148 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840835 STRAITH DRAIN INSERTER Surgical Technology Laboratories, Inc. FZX Class I 1984-04-23
K840541 NEURO SPONGE Surgicot, Inc. GDY Class I 1984-04-23
K840318 CAT. 14-CLINICAL TOXIOLOGY DEVICES Imm Enterprises , Ltd. HTD Class I 1984-04-23
K840536 CRYO SURG 5900 Frigitronics of Connecticut, Inc. GEH Class II 1984-04-23
K834572 EPITRON SUPER Leo Unlimited, Inc. KCW Class I 1984-04-23
K840137 SILGMANN SOLARIUM S-TYPE 1218 COMBO Tannhut FTC Class II 1984-04-23
K832983 DERMOLAS Meditec, Inc. GEX Class II 1984-04-23
K833735 AN ODOR ABSORBENT BANDAGE American Medical Disposable, Inc. NAB Class I 1984-04-23
K840766 JANACEK TUBO-UTERINE IMPLANTATION SET Cimed Intl., Inc. HTD Class I 1984-04-23
K834142 ADHESIVE TRACTION TAPE Devon Industries, Inc. GAD Class I 1984-04-23
K840684 FPP ARMBOARD STRAP Fpp, Inc. FWZ Class I 1984-04-23
K840585 SURG-A-STAT FINE TIP 2 Suncoast Medical Manufacturers, Inc. GEI Class II 1984-04-23
K834410 DOUBLE-COAGULATION SWITCHPEN 757 Olsen Electro-Surgical Instruments, Inc. GEI Class II 1984-04-04
K833946 EPILOT 80 S TM Leo Unlimited, Inc. KCW Class I 1984-04-04
K840831 ENDOTOME PNEUMATIC ORTHOPAEDIC CUT Cabot Medical Corp. HSZ Class I 1984-04-04
K834048 BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO Castle Co. GEI Class II 1984-04-04
K833176 SDI SURGICAL DRAPE Sdi KKX Class II 1984-04-04
K834329 OLSEN 756 ROCKER SWITCHPEN Olsen Electro-Surgical Instruments, Inc. GEI Class II 1984-04-04
K833499 FIBERLAS 100 MEDICAL SYSTEM Fiberlase U.S.A. LNK Class II 1984-04-02
K840343 PDI PREPMASTER WET PACK VAGINAL-X21477 Nice-Pak Products, Inc. KGO Class I 1984-03-27
K834350 ACUFEX DREZ COMMUNICATING DRILL GUIDE Acufex Microsurgical, Inc. FZX Class I 1984-03-19
K840229 CONTROL COVER GOWN Kimberly-Clark Corp. FYC Class II 1984-03-19
K840021 OPERATING ROOM TRAY SET Medi-Plast Intl., Inc. FSM Class I 1984-03-15
K840307 CAT. 3 GASTROENTEROLOGY-UROLOGY DEV Imm Enterprises , Ltd. HTD Class I 1984-03-12
K840317 CAT 13-CLINICAL CHEMISTRY DEVICES Imm Enterprises , Ltd. HTD Class I 1984-03-12
K840319 CAT 15-HEMATOLOGY & PATHOLOGY DEVICE Imm Enterprises , Ltd. HTD Class I 1984-03-12
K834514 FASCIA CUTTER Stryker Corp. GES Class I 1984-03-12
K840470 SURGISCRIBE MARKING PEN Surgicot, Inc. FZZ Class I 1984-03-12
K840309 CAT. 5-RADIOLOGY DEVICES Imm Enterprises , Ltd. HTD Class I 1984-03-12
K840306 CATEGORY 2 GEN. HOSPITAL & PERSONAL USE Imm Enterprises , Ltd. HTD Class I 1984-03-12
K834267 LIGACLIP METALLIC LIGATING CLIP ETHICON, Inc. FZP Class II 1984-03-12
K840320 CAT. 16-IMMUNOLOGY DEVICES Imm Enterprises , Ltd. HTD Class I 1984-03-12
K840316 CAT 12-ORTHOPEDIC & REHAB DEVICE Imm Enterprises , Ltd. HTD Class I 1984-03-12
K840110 LAERDAL SUCTION UNIT Laerdal Medical Corp. BTA Class II 1984-03-12
K840489 DISPOSIQUET A DISPOS. TOURNIQUET Med Lab Products GAX Class I 1984-03-12
K840651 MOLE-MARKER Notation Systems, Inc. FTY Class I 1984-03-12
K840422 DEVON HEAD REST Devon Industries, Inc. FWZ Class I 1984-03-12
K840421 ULNAR NERVE PROTECTOR Devon Industries, Inc. FWZ Class I 1984-03-12
K840315 CAT 11- GENERAL & PLASTIC SURGERY DEV Imm Enterprises , Ltd. HTD Class I 1984-03-12
K834189 JAKOBI SURG. INSTRUMENTS #7 44/47 Imm Enterprises , Ltd. EPY Class I 1984-03-06
K840413 CEMENT RESTRICTOR American Ortomed Corp. JDK Class II 1984-03-05
K832441 SUTURE-AID BOOTIES Omega-Med Intl., Inc. KDC Class I 1984-03-05
K833626 FLORET FOAM PREP SPONGE Ritmed, Inc. GDY Class I 1984-02-17
K834127 INSTRUMENT TIP PROTECTION COVERS Devon Industries, Inc. LXZ Class I 1984-02-17
K834615 TRIPLE LUMEN INFUSIONCATHETERS- Medical Components, Inc. JCY Class I 1984-02-14
K833438 PREPACELL-STERILE-BONE MARROW ASPIR Applied Medical Devices, Inc. KDD Class I 1984-02-09
K833524 SUNBED/SUNROOF TANNING DEVICE J B Trading BV FTC Class II 1984-02-09
K834488 MERRITTAN SUN SYSTEM Interfit A.G. Dba/Int'L Tanning Sys FTC Class II 1984-02-09
K833557 MEDILAS LASER Endo Lase, Inc. LNK Class II 1984-02-07
K834495 UV-A SUNTANNING EQUIPMENT 1000-8000 Futuren, Inc. FTC Class II 1984-02-06
K833976 VANISH Parke-Davis Co. KGO Class I 1984-02-04
K840027 OPERATING ROOM STAND Healthmate, Inc. FSE Class I 1984-02-04
K834493 EVERTAN SUNTAN BEDS Oregon Beauty Supply FTC Class II 1984-02-01
K833058 GEN. PURPOSE INSTRUMENT TRAYS & Inter-Med Corp. FSM Class I 1984-01-31
K834492 SALON -BODY TANNING BED Grantan FTC Class II 1984-01-31
K833586 TLS BULB DRAINAGE SYSTEM Porex Medical GCY Class I 1984-01-30
K832628 VYGON THORACIC DRAINAGE-VARIOUS #'S Exco, Inc. KDD Class I 1984-01-30
K833629 CERTAIN MANUAL SURG. INSTRU. ACCESS Cimed Intl., Inc. HTD Class I 1984-01-30
K834195 JAKOBI SURG. INSTRUMENTS #11 11/13/14 Imm Enterprises , Ltd. GES Class I 1984-01-27
K834095 BIOPSY FORCEPS Micro Vasive, Inc. GEN Class I 1984-01-27
K834176 H.R. JAKOBI SURG. INSTRUMENTS 40/41 Imm Enterprises , Ltd. GEG Class I 1984-01-27
K833350 KOSMEDICO GMBH SUN LAMP Kosmedico, Kosmetische & Medizinisch FTC Class II 1984-01-27
K834491 UVA SUNTANNING LAMPS D.P.R.M., Inc. FTC Class II 1984-01-27
K834069 ARTHROSCAN VIDEO SYSTEM Concept, Inc. FWF Class I 1984-01-27
K834175 OP-CON SURG. INSTRUMENTS #11 Imm Enterprises , Ltd. HRQ Class I 1984-01-27
K833355 SDC VASCULAR TIES Science Development Corp. KDC Class I 1984-01-27
K834541 H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 Imm Enterprises , Ltd. GDX Class I 1984-01-27
K834197 JAKOBI SURG. INSTR- #11 38/39/45/46/67 Imm Enterprises , Ltd. EMF Class I 1984-01-27
K833490 SILGMANN SOLARIUMS-TYPE 1218 CANOPY & Life Image, Inc. FTC Class II 1984-01-27
K832765 FLEXI-TY Bd Becton Dickinson Vacutainer Systems Preanalytic GAD Class I 1984-01-27
K833527 UV-A SUN TANNING EQUIPMENT Tan America Mfg. FTC Class II 1984-01-27
K834194 JAKOBI SURG. INSTRUMENTS #1 19/10/26 Imm Enterprises , Ltd. GES Class I 1984-01-27
K834184 H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 Imm Enterprises , Ltd. EMF Class I 1984-01-27
K833240 INT'L TANNING SYSTEMS B.V Business Contacts USA FTC Class II 1984-01-27
K833075 WET DRESSING KIT Clinipad Corp. KDD Class I 1984-01-27
K832794 SUNTANNING BOOTHS AND BEDS Tan-N-Trim FTC Class II 1984-01-27
K834196 JAKOBI SURG. INSTRUMENTS #11 20/25/27/37 Imm Enterprises , Ltd. GAD Class I 1984-01-27
K834542 H.R. JAKOBI SURG. INSTRU. SECT. 48 Imm Enterprises , Ltd. HTD Class I 1984-01-27
K834185 JAKOBI SURG. INSTRUMENTS #11 14/45 Imm Enterprises , Ltd. HTD Class I 1984-01-27
K833511 UV-A SUNTANNING EQUIPMENT-SILGMANN Thomas G. Mason FTC Class II 1984-01-27
K834183 H.R. JAKOBI SURG. INSTRUMENTS #11 25/39 Imm Enterprises , Ltd. HTD Class I 1984-01-27
K832448 TRIFLEX SURGEON'S GLOVES Travenol Laboratories, S.A. KGO Class I 1984-01-27
K834180 H.R. JAKOBI SURG. INSTRUMENTS #11 13/20 Imm Enterprises , Ltd. HTD Class I 1984-01-27
K834181 H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 Imm Enterprises , Ltd. GAD Class I 1984-01-27
K834182 H.R. JAKOBI SURG. INSTRUMENTS #11 27/37 Imm Enterprises , Ltd. GES Class I 1984-01-27
K833467 SURE-CUT Diverse Technologies, Inc. GDX Class I 1984-01-27
K834198 JAKOBI SURG. INSTRUMENTS #12 40/41 Imm Enterprises , Ltd. FZO Class I 1984-01-27
K833698 AMER. V. MUELLER SURG. STAPLES ILA American Heyer Schulte GDW Class II 1984-01-25
K834532 STERILE WET DRESSING PACK W.G. Whitney Corp. KDD Class I 1984-01-25
K831118 PMT-OPTICA LINE Pmt, Inc. KDC Class I 1984-01-25
K833121 BURLINGTON STERILE ANTIMICROBIAL STOCK Balfour, Inc. KKX Class II 1984-01-25
K833122 BURLINGTON ANTIMICROBIAL STOCKINEETTE Balfour, Inc. KKX Class II 1984-01-25
K833877 SINGLE-USE SURGICAL DRAPES Procter & Gamble Mfg. Co. KKX Class II 1984-01-25
K830294 MEDICAL EXAM TABLE Coe Laboratories, Inc. LGX Class I 1984-01-11
K833764 STERILIZATION OF GORE-TEX SOFT TISSU W. L. Gore & Associates, Inc. FTL Class II 1984-01-10
K831703 COVERUPS The Urology Group NAD Class I 1984-01-03
K833729 ELASTIC BREATHABLE OVER-WRAP BANDAGE American Medical Disposable, Inc. NAD Class I 1983-12-30
K833704 AMER. V. MUELLER SURGICALSTAPLES-CARTR American Heyer Schulte GDW Class II 1983-12-29
K833940 TORQUE PLUS CATALOG 30120 Concept, Inc. HWE Class I 1983-12-28
K833664 ARMBOARD AND THE BOARD Rick Robbin & Frederick Auerbach BTX Class I 1983-12-27

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