meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
49
Latest Decision
1987-03-05

Clearances · page 138 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K870417 RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY North Coast Medi-Tek FSM Class I 1987-03-05
K870591 ELEVATOR, COBB SPINAL Military Engineering, Inc. GEG Class I 1987-02-26
K870543 STERI-TRACTOR WOUND RETRACTOR 3M Company GAD Class I 1987-02-24
K870258 BIOSCRUB SURGICAL SCRUB BRUSH K. W. Griffen Co. GEC Class I 1987-02-24
K870282 4 X 4 SPONGES, NON-STERILE The Medical Group, Inc. NAB Class I 1987-02-24
K870312 WHITE PLUME SURGICAL GAUZE FACE MASK China National Medicines & Health Prod. I/E Corp. FXX Class II 1987-02-24
K870157 OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER Micro-Aire Surgical Instruments, Inc. KFK Class I 1987-02-24
K870283 3 X 3 SPONGES, NON-STERILE The Medical Group, Inc. NAB Class I 1987-02-24
K864388 MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY Deroyal Industries, Inc. KKX Class II 1987-02-20
K864969 JMS HALO APPLICATION TRAY Jerome Medical KDD Class I 1987-02-18
K870329 ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 Biodynamic Technologies, Inc. HTR Class I 1987-02-13
K870349 BIODYNAMICS FEMORAL CANAL BRUSH #1201 Biodynamic Technologies, Inc. HTR Class I 1987-02-13
K870333 BIODYNAMICS SMALL JOINT BRUSH #1203 Biodynamic Technologies, Inc. HTR Class I 1987-02-13
K870167 U.V. SUNLAMP 95UF-11 Light Sources, Inc. FTC Class II 1987-02-09
K870015 HCI ALL PURPOSE DRAIN/CATHETER SET Health Care Innovations, Inc. GBS Class I 1987-02-06
K864800 NAMIC CHIBA ASPIRATION BIOPSY NEEDLE North American Instrument Corp. GAA Class I 1987-02-06
K870098 LITHOTOMY HOLDERS Orthopedic Systems, Inc. FWZ Class I 1987-02-06
K870104 RADIOLUCENT TABLE EXTENSION Orthopedic Systems, Inc. FWZ Class I 1987-02-06
K870014 HCI GENERAL PURPOSE CATHETER STYLET Health Care Innovations, Inc. KGZ Class I 1987-02-06
K870185 BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) Fraass Survival Systems, Inc. NAD Class I 1987-02-06
K870101 CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION Orthopedic Systems, Inc. FWZ Class I 1987-02-06
K870056 TECNOL CLASSIC CONE MASK Tecnol New Jersey Wound Care, Inc. FXX Class II 1987-02-06
K870239 DRESSING, BURN, 24 BY 36 INCHES Fraass Survival Systems, Inc. NAD Class I 1987-02-06
K864771 CHUCK HANDLE New England Surgical Instrument Corp. GEI Class II 1987-02-04
K862514 OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO Laserscope GEX Class II 1987-02-04
K864510 PSORALITE 12800 SERIES Psoralite Corp. FTC Class II 1987-02-04
K870123 SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM Avery Intl. KKX Class II 1987-02-04
K864511 PSORALITE 18400 SERIES Psoralite Corp. FTC Class II 1987-02-04
K870124 SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM Avery Intl. KKX Class II 1987-02-04
K870122 SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM Avery Intl. KKX Class II 1987-02-04
K870126 FEMUR WRENCH Orthopedic Systems, Inc. GEG Class I 1987-02-03
K850100 BLOOD LANCET Gainor Medical FMK Class II 1987-01-29
K864929 HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST Hall Surgical, Division of Zimmer, Inc. HWE Class I 1987-01-28
K870017 AMG + MED LANCET Can-Am Surgical Corp. FMK Class II 1987-01-21
K864810 LIDSPLINT Precision Therapeutics, Inc. HMP Class I 1987-01-20
K864899 SURGICAL DRAPE PACK Webster Enterprises, Inc. KKX Class II 1987-01-20
K865094 LINEN (HUCK) TOWEL The Eye Co-Op, Inc. KKX Class II 1987-01-20
K864402 BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE New England Surgical Instrument Corp. GEI Class II 1987-01-20
K864688 ARNOLD-KING PRESSURE DRESSING Angiosystems, Inc. NAD Class I 1987-01-12
K865016 BLOOD LANCET Falcon Medical Industries, Inc. FMK Class II 1987-01-12
K865024 ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER American Container Technology, Inc. FWZ Class I 1987-01-12
K864919 SCANLAN (TM) VEIN/GRAFT HOLDER Scanlan Intl., Inc. KPK Class II 1987-01-12
K865022 SURGICAL GARMENTS Ulti-Med Intl., Inc. FXO Class I 1987-01-12
K864920 SCANLAN (TM) INSTRUMENT TRAY Scanlan Intl., Inc. FSM Class I 1987-01-12
K864670 BOARD, ARM (WITH COVER) Anago, Inc. BTX Class I 1987-01-12
K864897 DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 Dale Medical Products, Inc. GAX Class I 1987-01-12
K865023 COVER, SHOE OPERATING ROOM Ulti-Med Intl., Inc. FXP Class I 1987-01-12
K864546 MAXI-TAN DEVICE National Biological Corp. FTC Class II 1987-01-09
K864851 MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR Valleylab, Inc. GEI Class II 1987-01-08
K864785 AMOENA BREAST FORMS Coloplast Corp. GBI Class I 1987-01-08
K864786 PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT Coloplast Corp. GBI Class I 1987-01-08
K864675 MODEL FORCE 4B ELECTROSURGICAL GENERATOR Valleylab, Inc. GEI Class II 1987-01-08
K864907 SUNTANNING LAMP Interlectric Corp. FTC Class II 1987-01-05
K863580 DERMATEC TRANSPARENT FILM DRESSING Dermatec, Inc. NAD Class I 1986-12-31
K864881 ARTHROSCOPIC ANKLE HOLDER Orthopedic Systems, Inc. FWZ Class I 1986-12-29
K864880 COLLINS POSITIONING DEVICE Orthopedic Systems, Inc. FWZ Class I 1986-12-29
K864264 TRICOTEX WOUND CONTACT LAYER DRESSING Smith & Nephew, Inc. NAB Class I 1986-12-29
K864550 CARETEX SHOE COVERS James River Corp. FXP Class I 1986-12-24
K864291 HIGH FREQUENCY NEEDLE-TYPE EPILATOR Multi-Channel Epilator KCW Class I 1986-12-24
K864551 BIOPSY ADAPTER #H4221BG General Electric Co. GDF Class I 1986-12-23
K864350 VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER ETHICON, Inc. FZP Class II 1986-12-18
K864697 CK 6000 SERIES, TOWELS Currie Medical Specialties, Inc. KKX Class II 1986-12-18
K864521 ANGEL LATEX SURGICAL GLOVES Kim Intl. Trading Co. KGO Class I 1986-12-18
K864485 SUNFIT SUNLAMP Sunfit, Inc. FTC Class II 1986-12-17
K864529 LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 Elof Hansson, Inc. GDY Class I 1986-12-16
K864608 ADOBE ENTERPRISES SURGICAL/BANDAGE SCISSORS FORCEP Adobe Ent. GEN Class I 1986-12-16
K864425 RAYLOR(TM) DISSECTING HOOK Cedar Surgical, Inc. GDG Class I 1986-12-12
K864479 CARETEX ISOLUTION GOWNS James River Corp. FYC Class II 1986-12-09
K864381 LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM Luxtec Corp. FWC Class I 1986-12-09
K861985 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) 3M Company MVR Class II 1986-12-04
K863086 SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG Cooper Lasersonics, Inc. GEX Class II 1986-12-04
K863428 SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG Laser Media LNK Class II 1986-12-03
K864459 RAIL CLAMP EXTENSION PIECE American Container Technology, Inc. FWZ Class I 1986-12-01
K864289 MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR Alexander Thomas, Inc. KCW Class I 1986-12-01
K864421 RAYLOR(TM) PERIOSTEAL ELEVATORS Cedar Surgical, Inc. GEG Class I 1986-11-26
K864424 RAYLOR(TM) PROTECTIVE RETRACTOR Cedar Surgical, Inc. GAD Class I 1986-11-26
K864311 STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) Clinitech, Inc. FYA Class II 1986-11-26
K863578 DERMATEC ZONE TRANSPARENT DRESSING Dermatec, Inc. NAD Class I 1986-11-25
K863583 CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER Laser Media LNK Class II 1986-11-24
K864011 EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES Fraass Survival Systems, Inc. NAD Class I 1986-11-22
K861179 CANDELA MODEL SPT-1, PULSED DYE LASER Candela Corp. GEX Class II 1986-11-20
K864325 DR7700 OPERATING TABLE Koken Mfg Company, Inc. FQO Class I 1986-11-19
K864384 LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS Luxtec Corp. GAD Class I 1986-11-19
K862598 LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM Laserscope LNK Class II 1986-11-19
K864380 LUTEX HEADLIGHT SYSTEMS Luxtec Corp. FST Class II 1986-11-19
K864314 EFTEKHAR RECHANNELIZATION DRILL GUIDE The Anspach Effort, Inc. HSZ Class I 1986-11-19
K864295 DR.500O OPERATING TABLE Koken Mfg Company, Inc. FQO Class I 1986-11-19
K864371 SURGICAL SKIN MARKER Myocure, Inc. FZZ Class I 1986-11-17
K864386 LUXTEC LOUPES FOR SURGICAL VISION Luxtec Corp. FSP Class I 1986-11-17
K864165 MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES Mbk Medical Gloves Co., Ltd. KGO Class I 1986-11-17
K862815 LASER SURGICAL ROD Lifestream Int'L, Inc. GEX Class II 1986-11-17
K864193 GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN Gaw, Inc. GDM Class I 1986-11-17
K864137 LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III Bio-Rad KIJ Class I 1986-11-07
K864072 ADEC 1005-C CHAIR Cherne Industries, Inc. LGX Class I 1986-11-07
K864115 TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU Cathaid, Inc. KGZ Class I 1986-11-07
K864102 LIGACLIP 20/20* MULTIPLE CLIP APPLIER ETHICON, Inc. FZP Class II 1986-11-05
K864139 RANFAC CUT BIOPSY NEEDLE Ranfac, Corp. GAA Class I 1986-11-05
K864146 DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) Cardio Thoracic Systems GDW Class II 1986-11-05
K863937 OSRAM ULTRAMED 400 W Osram GmbH FTC Class II 1986-11-04
K862875 E-VAC(TM) Laerdal California, Inc. BTA Class II 1986-11-03

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