meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
40
Latest Decision
1989-08-23

Clearances · page 128 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K894354 SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES Safeskin Corp. KGO Class I 1989-08-23
K885018 ABSORBABLE SURGICAL GUT SUTURE* United States Surgical, A Division of Tyco Healthc GAL Class II 1989-08-22
K894685 DAVIS+GECK VISADUCT KIT Davis & Geck, Inc. LRO Class II 1989-08-22
K894771 EPILATION NEEDLE Precision Electrolysis Needles, Inc. KCW Class I 1989-08-21
K894438 MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS Micro-Aire Surgical Instruments, Inc. GFF Class I 1989-08-21
K894760 CLOTHINGUARD Barrier Concepts, Inc. FYE Class I 1989-08-18
K894764 OR TOWEL PACKS Advance Medical Designs, Inc. KKX Class II 1989-08-18
K894119 MADEGOM LTDA. PENROSE DRAIN TUBING Madegom GBW Class I 1989-08-18
K894474 THE AUTOLET LITE Ulster Scientific, Inc. FMK Class II 1989-08-18
K894785 SURGICAL CHISEL/OSTEOTOME Fdt Precision Machine Co., Inc. KDG Class I 1989-08-18
K894455 DECONTAMINATING KIT, SKIN: M291 Dept. of the Army MAC Class I 1989-08-15
K891471 SIL-MED WASTE FLUID DUMP BAG Sil-Med Corp. KDG Class I 1989-08-15
K894436 MASCOT O.R. TOWEL Mascot, Inc. KKX Class II 1989-08-11
K894064 STERILE HAND COVER Sage Products, Inc. LYU Class I 1989-08-11
K894433 BATES BLANKET Joe B. Bates, MD, FAAP KKX Class II 1989-08-11
K894599 SHIRT, OPERATING, SURGICAL Miroz Industries Co. FYA Class II 1989-08-11
K893995 DERMACARE TIE HOLDER Dermacare KGS Class I 1989-08-11
K894397 WELCON LIGHT HANDLE Welcon, Inc. FTA Class II 1989-08-10
K893956 EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM Living Technology, Inc. GEX Class II 1989-08-10
K894501 AMMEL STERILE SURGEON'S GLOVES Mauricio Menconi KGO Class I 1989-08-10
K894210 SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS Sharplan Lasers, Inc. GEX Class II 1989-08-10
K894211 SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS Sharplan Lasers, Inc. GEX Class II 1989-08-10
K893814 SURGICAL INSTRUMENT KIT, DISPOSABLE Bioseal LRO Class II 1989-08-10
K894066 SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX Sharplan Lasers, Inc. GEX Class II 1989-08-10
K894602 B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) Beacon Laboratories, Inc. GEI Class II 1989-08-09
K890450 INTERMEDICS APR(TM) II FEMORAL COMPONENT Intermedics Orthopedics JDJ Class II 1989-08-09
K893832 CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER Heraeus Lasersonics, Inc. GEX Class II 1989-08-09
K894396 SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER Surgilase, Inc. GEX Class II 1989-08-07
K893949 #157 EXAM LIGHT Medmark, Inc. KFK Class I 1989-08-07
K893871 GOOTT BALFOUR BLADE Adept-Med Intl., Inc. GAD Class I 1989-08-03
K894301 MICRO-AIRE STERNUM SAW 4800 Micro Surgical Instruments Corp. KFK Class I 1989-08-03
K893869 GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) Adept-Med Intl., Inc. GAD Class I 1989-08-03
K893842 CYSTO APRONS IN VARIOUS SIZES Bemiss Jason Corp. LYU Class I 1989-08-02
K892837 STERIL-DERM TRANSPARENT WOUND DRESSING Biointerface Technologies, Inc. NAD Class I 1989-08-01
K894393 OPMILAS CO2-L Carl Zeiss, Inc. GEX Class II 1989-07-27
K892237 THE FERN CRYOPROBE Cryogenic Instruments & Equipment , Ltd. GEH Class II 1989-07-25
K891820 DISPOSABLE MEDICAL GOWNS Bioshield, Inc. FYB Class II 1989-07-24
K894326 THORACENTISIS KIT Mill-Rose Laboratory GAA Class I 1989-07-24
K893828 ML-800 AUTOELECTRONIC LIGHT SOURCE M.P. Video, Inc. FST Class II 1989-07-24
K892389 BIOPSY KIT I M, Inc. LRO Class II 1989-07-17
K884495 SURGICAL GLOVES Sanko Chemical Industry Co., Ltd. KGO Class I 1989-07-14
K894284 GOWN, OPERATING, SURGICAL Miroz Industries Co. FYA Class II 1989-07-14
K893642 MODIFIED ENDOGUIDE Luxar Corp. GEX Class II 1989-07-14
K893732 ASPEN DISPOSABLE BIPOLAR CORD Conmedcorp GEI Class II 1989-07-14
K893659 ELECTROSURGERY ANALYZER RF302 Bio-Tek Instruments, Inc. GEI Class II 1989-07-14
K893939 ISOLATION MASKS James River Corp. FXX Class II 1989-07-14
K893813 FLOOR STANDING, OPERATING AND EXAMINING LIGHT Astralite Corp. FSS Class II 1989-07-14
K894034 MODIFIED LABELING OF SURGICAL GLOVES James River Corp. KGO Class I 1989-07-14
K893603 REMOVE ADHESIVE REMOVER Smith & Nephew United, Inc. KOX Class I 1989-07-14
K893870 ADAMS BREAST IMPLANT PROTECTOR Adept-Med Intl., Inc. GCZ Class I 1989-07-14
K893969 DECUBITUS CARE PAD Gulftrade Exim, Inc. FWZ Class I 1989-07-14
K893702 TECNOL GAITERS PRODUCT NUMBER 47725-010 Tecnol New Jersey Wound Care, Inc. FXP Class I 1989-06-23
K893634 MODIFIED STERILIZATION OF TUR APRONS Brant-Wald Surgicals, Inc. FXX Class II 1989-06-23
K893480 BYRD EXTRACTOR SET Medical Engineering and Development Institute GCC Class I 1989-06-23
K893491 MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 Cuda Products Co. FST Class II 1989-06-22
K893417 SURGIFRESH SUB-MICRON MASK NO. 901008-000 Texas Medical Products, Inc. FXX Class II 1989-06-22
K885089 SURGICAL GLOVES Wb Intl., Inc. KGO Class I 1989-06-22
K892933 INFRALASE-LASERGUIDE DELIVERY SYSTEM Ximed Medical Systems GEX Class II 1989-06-22
K893406 DESERET PRN ADAPTER Deseret Medical, Inc. KGZ Class I 1989-06-22
K893701 SLT CONTACT LASER SYSTEM Surgical Laser Technologies, Inc. GEX Class II 1989-06-21
K893206 SHARPLAN 1075 CO2 LASER Sharplan Lasers, Inc. GEX Class II 1989-06-21
K893340 LATEX SURGICAL GLOVES Kenmark Industrial Co., Ltd. KGO Class I 1989-06-21
K892808 KINETIC MODEL 700 Kinetic Biomedical Services, Inc. FSY Class II 1989-06-15
K891282 MIC-100 WITH CRYOPROBES Frigitronics of Connecticut, Inc. GEH Class II 1989-06-15
K892516 CANDELA PLDL-1 PULSED DYE LASER Candela Laser Corp. GEX Class II 1989-06-15
K891584 S 22 INSTRUMENT STAND Carl Zeiss, Inc. HRM Class I 1989-06-08
K893529 COMBOLASER MODEL 5050 Lasermatic, Inc. GEX Class II 1989-06-08
K892056 SURGICAL LATEX STERILE GLOVES Modern Rubber Industrial Co., Ltd. KGO Class I 1989-06-08
K891998 BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 Elwyn Industries NAD Class I 1989-06-05
K893389 MODEL SE-5 EPILATOR R. A. Fischer Co. Corp. KCW Class I 1989-06-05
K885257 EAGLE - NEODYUMIUM DOPED YTTRIUM ALUMINUM GARNET Living Technology, Inc. GEX Class II 1989-06-05
K885170 LASERCOMP MODEL: 10 STAR 10 Laser-West GEX Class II 1989-06-05
K885029 HOUVA II UVA/UVB National Biological Corp. FTC Class II 1989-06-02
K885026 HOUVA II UVB National Biological Corp. FTC Class II 1989-06-02
K885060 PEGASUS Pfizer Laser Systems GEX Class II 1989-06-02
K893118 AOR-SULLIVAN PROTECTIVE OVERGLOVE Aor-Sullivan LYU Class I 1989-06-01
K893212 THERMALAP O.R. Concepts, Inc. KKX Class II 1989-06-01
K893121 ROBOTRAC (TM) RETRACTOR ARM Aesculap Instruments Corp. GAD Class I 1989-06-01
K891459 STERILE BURNNET PRE-CUT (VARIOUS SIZES) Western Medical, Ltd. NAD Class I 1989-05-26
K891917 ORTHO-J, INC. BEK-JS-004 Ortho-J, Inc. JEB Class I 1989-05-26
K891909 LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS Lifestream Int'L, Inc. GEX Class II 1989-05-26
K893033 MINI-DIAMOND KNIFE L.A.B. Instruments GDX Class I 1989-05-26
K892823 PLASTER CUTTING SCISSORS The South India Surgical Co. Pvt. , Ltd. LRW Class I 1989-05-25
K884882 ORIENT, LATEX SURGICAL GLOVES, STERILE Rosa Intl. KGO Class I 1989-05-24
K882558 AREOLA/NIPPLE DRESSING Cooper Surgical/Aesthete NAD Class I 1989-05-24
K891387 WILLIAMS BELT & BOOT Arthro-Medic, Inc. JEB Class I 1989-05-23
K892061 GRAND GUARD SURGICAL GLOVES Galaxy Intl., Inc. KGO Class I 1989-05-23
K893013 LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE Luxar Medical Laser Instruments GEX Class II 1989-05-23
K890603 BEAM TECH WOUND DRESSING* Beam Tech , Ltd. NAD Class I 1989-05-23
K891130 LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC Lifestream Int'L, Inc. GEX Class II 1989-05-23
K892211 HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS Heraeus Lasersonics, Inc. GEX Class II 1989-05-19
K890445 PERSONAL ALERT ASSIST DEVICE Silent Call Corp. LXI Class I 1989-05-19
K890922 ACCU-BEAM YAG FIBER Tti Medical GEX Class II 1989-05-15
K892451 SAFE-T-FACE DISPOSABLE FACE SHIELD Barry S. Smith Co. FXX Class II 1989-05-15
K892502 ELECTROSURGICAL PENCIL Yuntek International, Inc. GEI Class II 1989-05-15
K890084 PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000 Psoralite Corp. FTC Class II 1989-05-11
K892527 DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY Convatec, A Division of E.R. Squibb & Sons NAD Class I 1989-05-11
K885271 BDAC OMICRON PLUS SURGICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1989-05-08
K890570 SKIN SCRUB KIT Kit Pak, Inc. LRO Class II 1989-05-05
K890289 DIVERSI-MED STERILE LATEX SURGEON'S GLOVES Diversi Group, Inc. KGO Class I 1989-05-05

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