meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
43
Latest Decision
1991-01-31

Clearances · page 122 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K904972 SURGICARE STERILE SURGICAL GLOVES Kanam Latex Industries Pvt. , Ltd. KGO Class I 1991-01-31
K905106 AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 1991-01-31
K905082 PEGASUS WITH ACCESSORIES Pfizer Laser Systems GEX Class II 1991-01-31
K905268 FLOWERS JOWL IMPLANT Implantech Associates, Inc. FWP Class II 1991-01-31
K905105 JAIN SUTURE/VESIBAND ORGANIZER Jain Surgical Equipment, Inc. MDM Class I 1991-01-31
K905267 FLOWERS CHIN IMPLANT Implantech Associates, Inc. FWP Class II 1991-01-31
K905440 FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE United States Surgical, A Division of Tyco Healthc GAS Class II 1991-01-31
K905069 IODOSORB GEL Perstorp AB C/O Robert Joel Slomoff KOZ Class I 1991-01-31
K904535 LU-TEX II Lukens Medical Corp. GAS Class II 1991-01-30
K904931 AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* United States Surgical, A Division of Tyco Healthc GAR Class II 1991-01-29
K901853 MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS Johnson & Johnson Medical, Inc. NAD Class I 1991-01-28
K905733 SEROMA-CATH CLOSE DRAINAGE SYSTEM Dawn Medical GCY Class I 1991-01-28
K904769 SENSITOUCH Ansell Intl. KGO Class I 1991-01-28
K904911 DISPOSABLE FIBER OPTIC DELIVERY SYSTEM Fiber Delivery Concepts, Inc. GEX Class II 1991-01-25
K904993 LAPAROSCOPIC ELECTROSURGICAL DEVICE Everest Medical Corp. GEI Class II 1991-01-25
K910031 PARK CITY SHOULDER POSITIONER Orthopedic Systems, Inc. FWZ Class I 1991-01-24
K905637 ILLUMINA MODEL 780 CO2 LASER SYSTEM Heraeus Lasersonics, Inc. GEX Class II 1991-01-18
K905379 AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP United States Surgical, A Division of Tyco Healthc GAR Class II 1991-01-17
K905393 HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR Frigitronics, Inc. FWF Class I 1991-01-16
K905587 AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE United States Surgical, A Division of Tyco Healthc FZP Class II 1991-01-16
K904965 SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 Smith & Nephew Equipment Group FSY Class II 1991-01-16
K904821 ELIACHAR MODIFIED ESOPHAGEAL STENT Hood Laboratories ESW Class II 1991-01-14
K905233 MOOR LASER BLOOD FLOW MONITOR MBF3D Moor Instruments, Ltd. GEX Class II 1991-01-11
K905537 PERRY XTENDA CUFF SURGICAL GLOVES Smith & Nephew Perry KGO Class I 1991-01-11
K904662 SRI JOHANI LATEX SURGEONS GLOVES Transcorp KGO Class I 1991-01-11
K905232 MOOR LASER BLOOD FLOW MONITOR MBF3 Moor Instruments, Ltd. GEX Class II 1991-01-11
K904903 PARADERM(TM) SURGEON'S GLOVE ACCESSORY Lovell-Schenck, Inc. LYU Class I 1991-01-08
K905277 MICRO-AIRE 4220-000 OSCILLATING SAW Micro Surgical Instruments Corp. HSZ Class I 1991-01-08
K904629 CENTAURI YAG LASER SYST, UROLOGY Pfizer Laser Systems GEX Class II 1991-01-07
K904604 REDI-RELEASE ABSORBENT DRESSING Fountain Pharmaceuticals, Inc. KOZ Class I 1991-01-07
K904628 CENTAURI YAG LASER SYST, GASTROENTEROLOGY Pfizer Laser Systems GEX Class II 1991-01-07
K904627 CENTAURI YAG LASER SYST, EAR, NOSE , THROAT Pfizer Laser Systems GEX Class II 1991-01-07
K904808 ELECTROSURGICAL PENCIL Megadyne Medical Products, Inc. GEI Class II 1991-01-04
K904693 CUSTOMED CARDIOVASCULAR PACK Customed, Inc. KKX Class II 1991-01-02
K904694 CUSTOMED ANGIODRAPE PACK FEMORAL Customed, Inc. KKX Class II 1991-01-02
K903117 ORION STERILE OR TOWELS Orion Life Systems, Inc. KKX Class II 1990-12-31
K904560 VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES Valleylab, Inc. GEI Class II 1990-12-31
K905655 NONABSORBABLE POLYPROPYLENE SURGICAL MESH United States Surgical, A Division of Tyco Healthc FTL Class II 1990-12-31
K904545 FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET Valleylab, Inc. GEI Class II 1990-12-28
K904644 EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 Eurosun, Inc. LEJ Class II 1990-12-28
K904427 PANOSOL II UVB-206 National Biological Corp. FTC Class II 1990-12-24
K904428 PANOSOL II UAB-228 National Biological Corp. FTC Class II 1990-12-24
K904906 SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP Chathamborough Research Group, Inc. GAW Class II 1990-12-24
K903643 DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE Deknatel, Inc. GAW Class II 1990-12-24
K904426 PANOSOL II UVA-218 National Biological Corp. FTC Class II 1990-12-24
K904588 AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP United States Surgical, A Division of Tyco Healthc GAL Class II 1990-12-24
K905012 STERILE SURGICAL GLOVES/DOUBLE GLOVER American Advisors, Inc. KGO Class I 1990-12-21
K905478 YANKAUER SUCTION DEVICE Medovations, Inc. MDM Class I 1990-12-19
K904342 SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A Hgm Medical Laser Systems, Inc. GEX Class II 1990-12-19
K904354 LPI MULILASE YAG/532 SURGICAL LASER SYSTEM Laser Photonics, Inc. GEX Class II 1990-12-19
K905046 DERMABRADER Aaron Medical Industries GFE Class I 1990-12-19
K905187 BONE RASPS Micro Surgical Instruments Corp. HSZ Class I 1990-12-19
K904610 HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS Heraeus Lasersonics, Inc. GEX Class II 1990-12-19
K904682 VISTEK ELECTRONIC CONTROLLER Vistek Corp. GEY Class I 1990-12-18
K904407 DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG Fiber Delivery Concepts, Inc. GEX Class II 1990-12-18
K904609 XENON LIGHT SOURCE Medical Dynamics, Inc. HBI Class II 1990-12-18
K904656 FLOWERS NASAL IMPLANT Implantech Associates, Inc. FZE Class II 1990-12-18
K904681 VLS 5300 300W XENON LIGHT SOURCE Vistek Corp. HBI Class II 1990-12-18
K904657 FLOWERS DORSAL COLUMELLA IMPLANT Implantech Associates, Inc. FZE Class II 1990-12-18
K904630 CENTAURI YAG LASER SYST, OPHTHAMOLOGY Pfizer Laser Systems GEX Class II 1990-12-17
K904331 L.P.I. LASER DELIVERY SYSTEM Laser Photonics, Inc. GEX Class II 1990-12-17
K904389 SI-PRO David F. Trungale EYF Class I 1990-12-17
K904506 ACTIVE ADAPTER Beacon Laboratories, Inc. GEI Class II 1990-12-13
K904960 QUALTEX SURGICAL DRAPE Deroyal Industries, Inc. KKX Class II 1990-12-13
K904559 QUALTEX SKIN MARKER Qualtex, Inc. FZZ Class I 1990-12-13
K905380 1-CUT ACL GRAFT KNIFE Depuy, Inc. GDX Class I 1990-12-13
K904444 MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 Heraeus Lasersonics, Inc. GEX Class II 1990-12-13
K904423 CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM Heraeus Lasersonics, Inc. GEX Class II 1990-12-13
K904969 HOOD, OPERATING, SURGICAL Chicago Assoc. For Retarded Citizens FXY Class II 1990-12-12
K904227 MULTILASE 45 Laser Photonics, Inc. GEX Class II 1990-12-12
K904229 MULTILASE 60 Laser Photonics, Inc. GEX Class II 1990-12-12
K904667 NA NEEDLES Olympus Corp. GDM Class I 1990-12-12
K905005 DISPOSABLE SURGICAL TOWEL (NON-STERILE) Marand Products, Inc. KKX Class II 1990-12-11
K904436 QUICKANCHOR (TM) Mitek Surgical Products, Inc. GAS Class II 1990-12-11
K904361 KLEARTEX LATEX SURGEONS GLOVES Kleartex Sdn Bhd KGO Class I 1990-12-07
K904203 SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM Surgilase, Inc. GEX Class II 1990-12-07
K904402 NIDEK INC. MODEL AC-2000 DERM Nidek, Inc. GEX Class II 1990-12-07
K904896 EYE PAD Ulti-Med Intl., Inc. HMP Class I 1990-12-05
K903346 DISPOSABLE EMISSIONS BARRIER LASER DRAPE Wave-Form Systems, Inc. KKX Class II 1990-12-05
K904149 FLEXISYS Dornier Medtech America, Inc. GEX Class II 1990-12-04
K903358 ADVANCE LAPAROTOMY SPONGE, LAP SPONGE Advance Medical Designs, Inc. GDY Class I 1990-11-29
K904536 JAIN GRAFT ASSIST Jain Surgical Equipment, Inc. GCZ Class I 1990-11-29
K901536 STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV Depuy, Inc. FYA Class II 1990-11-29
K905161 RUBBER LATEX SURGICAL GLOVES, STERILE Rfb Latex Pvt. , Ltd. KGO Class I 1990-11-29
K904348 CUI FEATHERED SILICONE MALAR Cui Corp. LZK Class II 1990-11-26
K904349 CUI CURVILINEAR SILICONE CHIN Cui Corp. FWP Class II 1990-11-26
K902525 ACE/WILLIAMS MICROSURGERY SAW SYSTEM Buckman Co., Inc. HWE Class I 1990-11-26
K904350 CUI DORSAL COLUMELLA PROSTHESIS Cui Corp. FZE Class II 1990-11-26
K904949 A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS Micro-Aire Surgical Instruments, Inc. HSZ Class I 1990-11-26
K903154 CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER Trimedyne, Inc. GEX Class II 1990-11-23
K903416 CANNULA, SURGICAL Advantage Diagnostics Corp. GEA Class I 1990-11-23
K904111 HTR POLYMER, HTR-MX United States Surgical, A Division of Tyco Healthc KKY Class II 1990-11-23
K904155 MEDILAS 4060N FIBERTOM(R) SURGICAL LASER Dornier Medtech America, Inc. GEX Class II 1990-11-21
K903645 DERMASORB WOUND CONTACT LAYER DRESSING Convatec, A Division of E.R. Squibb & Sons KOZ Class I 1990-11-21
K904425 MODEL 6/01 UV-B FIXTURE Strato-Ray Co. FTC Class II 1990-11-21
K904276 DISPOSABLE BEARD COVER Anago, Inc. FXY Class II 1990-11-21
K903943 MODEL MC 1100 SURGICAL YAG LASER Klinger Micro-Controle Group GEX Class II 1990-11-21
K896828 BIOCLUSIVE(R) ABSORBENT DRESSING Johnson & Johnson International KOZ Class I 1990-11-21
K904352 CODMAN COLLINS RADIOPARENT STERNAL BLADES Codman & Shurtleff, Inc. DWH Class I 1990-11-21
K904172 ACCUPLACE (TM) Dlp, Inc. GDF Class I 1990-11-21

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