meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
53
Latest Decision
1988-03-25

Clearances · page 134 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881084 UTILITY CLAMP Med-Dex Intl. GDJ Class I 1988-03-25
K881060 OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) Orthopedic Systems, Inc. JEA Class I 1988-03-25
K871932 MODEL 5050 SURGILASER FOR UROLOGY USE Lasermatic, Inc. LNK Class II 1988-03-25
K880074 RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS Romano Surgical Instrumentation, Inc. HSZ Class I 1988-03-25
K880998 STERNUM SPREADER, PEDIATRIC T. Korossurgical Instruments Corp. GAD Class I 1988-03-21
K880869 MEDI-LET Medicore, Inc. FMK Class II 1988-03-21
K874157 LASE EVACUATOR/ASPIRATOR Lase, Inc. BTA Class II 1988-03-21
K880739 DYONICS DRILL GUIDE/ISOMETER SYSTEM Dyonics, Inc. LXI Class I 1988-03-21
K880942 REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) Repack Surgical Enterprises, Inc. LRO Class II 1988-03-21
K880859 SURGICAL BURS New England Surgical Instrument Corp. GFF Class I 1988-03-21
K880997 SPRING RETRACTOR T. Korossurgical Instruments Corp. GAD Class I 1988-03-21
K880669 L-5 PLASTIC SURGERY CANNULAS American Instrument Manufacturer'S, Inc. GEA Class I 1988-03-17
K881012 WOUND-EVAC RS Heritage Medical Products GCY Class I 1988-03-17
K880020 3 IN 1 AUTOMATIC TOURNIQUET Systematics Mfg. & Tool Co., Inc. KCY Class I 1988-03-17
K880263 OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION Orthopedic Systems, Inc. JEB Class I 1988-03-15
K875005 PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. Advanced Surgical Products, Inc. FST Class II 1988-03-14
K875006 PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK Advanced Surgical Products, Inc. FST Class II 1988-03-14
K875007 PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. Advanced Surgical Products, Inc. FST Class II 1988-03-14
K875004 PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK Advanced Surgical Products, Inc. FST Class II 1988-03-14
K880895 URESIL WOUND DRAIN TROCAR Uresil Corp. GBS Class I 1988-03-14
K880757 TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD Tecnol New Jersey Wound Care, Inc. FXX Class II 1988-03-11
K880785 SKILCRAFT Pennsylvania Association For the Blind KDD Class I 1988-03-11
K880513 DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE Taub Industries KKX Class II 1988-03-11
K880813 SELF-RETAINING SOFT TISSUE RETRACTOR T. Korossurgical Instruments Corp. GAD Class I 1988-03-11
K880206 POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER Laivan Corp. NAD Class I 1988-03-11
K880812 SPINAL NEEDLE T. Korossurgical Instruments Corp. GDM Class I 1988-03-11
K880603 COHERENT XA-40 CO2 SURGICAL LASER Coherent Medical Group GEX Class II 1988-03-11
K880064 YESNG MODEL 200S11 ELECTROSURGICAL UNIT Ferguson Medical GEI Class II 1988-03-11
K875008 GUARDALL SHIELD Anago, Inc. FXX Class II 1988-03-11
K880073 YESNG MODEL 500SII ELECTROSURGICAL UNIT Ferguson Medical GEI Class II 1988-03-11
K874554 ENVICLUSIVE (TM) Marion Laboratories, Inc. NAD Class I 1988-03-11
K875195 OPHTHALMIC LIGHT PIPE PICK Trek Medical Products, Inc. FST Class II 1988-03-07
K874825 DISPOSABLE CAUTERIES Midsouth Industries, Inc. GEI Class II 1988-03-04
K880150 PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM Dyonics, Inc. HWE Class I 1988-03-04
K880613 ACCO(R) FACE MASK Absorbent Cotton Co., Inc. FXX Class II 1988-03-04
K872996 NATURAL-TOUCH (TM) SURGEON'S GLOVE Hands-On Packaging , Ltd. KGO Class I 1988-03-04
K880216 MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. Directed Energy, Inc. GEX Class II 1988-03-04
K880035 DAEWOO LATEX SURGICAL GLOVE California Ent. KGO Class I 1988-03-04
K872573 PHARMACLUSIVE (TM) Pharmacia, Inc. NAD Class I 1988-02-29
K880094 VAN-TEC ENDOPYELOTOMY KNIFE Van-Tec, Inc. EMF Class I 1988-02-29
K880553 ELECTRONIC EPILATOR Clareblend, Inc. KCW Class I 1988-02-29
K875115 INFRAGUIDE(TM) Cooper Lasersonics, Inc. GEX Class II 1988-02-26
K880706 SURGICAL BURS Nuell Air Equipment & Hospital Supplies, Inc. GFF Class I 1988-02-26
K880540 LIGHT, SURGICAL, FLOOR STANDING Ferguson Medical FSS Class II 1988-02-24
K874798 MEDITRON BI-2000 BIPOLAR GENERATOR W/IRRIGATION Xylog Corp. GEI Class II 1988-02-24
K880650 HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS Baxter Healthcare Corp GCY Class I 1988-02-24
K880481 CARETEX SURGEON'S CAPS James River Corp. FYF Class I 1988-02-24
K880431 CARETEX SURGEON'S HOODS James River Corp. FXY Class II 1988-02-24
K874480 MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) Omikron Scientific, Ltd. NAD Class I 1988-02-22
K875033 STERILE SCRUBBY SCRUB BRUSH Medsurg Industries, Inc. GEC Class I 1988-02-19
K880441 PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. Plane Iii, Inc. FTY Class I 1988-02-18
K880405 SILASTIC NASAL IMPLANT S-TYPE Dow Corning Wright FZE Class II 1988-02-18
K880265 WEHBE ARM HOLDER Orthopedic Systems, Inc. FWZ Class I 1988-02-18
K880151 HIP, FEMUR AND HUMERUS RETRACTOR Twenty-First Century Orthopedics, Inc. GAD Class I 1988-02-18
K880227 ARTHROBOT(TM) LOWER LIMB POSITIONER Andronic Devices, Ltd. FQO Class I 1988-02-18
K875153 THIELER KIT Taris Corp. KKX Class II 1988-02-18
K875129 STERI-CLENS Absorbent Cotton Co., Inc. GEC Class I 1988-02-18
K874948 SUN MEDICAL SMOKE EVACUATOR SYSTEM Sun Medical, Inc. GEX Class II 1988-02-18
K880324 MICRO-AIRE CEMENT REMOVAL TOOLS Micro-Aire Surgical Instruments, Inc. HSZ Class I 1988-02-17
K880376 NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP Genesis Industries, Inc. GBS Class I 1988-02-16
K875349 STERILE SURGICAL NATURAL LATEX GLOVES Marand Products, Inc. KGO Class I 1988-02-16
K874719 STRATUM ESU Alternative Design Systems, Inc. JOS Class II 1988-02-16
K880244 SURGICAL BLADES Ailee C/O Havel'S, Inc. GES Class I 1988-02-10
K880198 GEMINI SURGICAL LIGHT American Sterilizer Co. FSS Class II 1988-02-10
K874811 MODEL 5202 MICROMANIPULATOR Coherent Medical Group GEX Class II 1988-02-05
K874648 COHERENT XA-30/SP CO2 SURGICAL LASER Coherent Medical Group GEX Class II 1988-02-04
K874775 ELECTRODE TIP CLEANER C.R. Bard, Inc. GEI Class II 1988-02-03
K873892 SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE Laserguide LNK Class II 1988-02-02
K874779 BIPOLATOR 50 Treace Medical, Inc. GEI Class II 1988-01-29
K880093 CARETEX SKID RESISTANT SHOE COVERS James River Corp. FXP Class I 1988-01-29
K875292 MICRODISCECTOMY CURETTE SET T. Korossurgical Instruments Corp. FZS Class I 1988-01-29
K880028 OMED DISPOSABLE SCALPEL Oxboro Medical Intl., Inc. GDX Class I 1988-01-29
K874512 MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM Stackhouse Assoc. FYD Class II 1988-01-27
K874411 DONALDSON NATURAL EYEPATCH 'PATIENT PAK' Keeler Instruments, Inc. HMP Class I 1988-01-27
K875305 MODEL UCA / SPEC SYSTEM UCA Spec Systems, Inc. FZH Class II 1988-01-27
K874552 ENVISAN PAD Marion Laboratories, Inc. KOZ Class I 1988-01-22
K875172 DISPOSABLE SURGICAL FACE MASK Irema USA , Ltd. FXX Class II 1988-01-22
K875291 SPINAL SURGERY FRAME T. Korossurgical Instruments Corp. BWN Class I 1988-01-22
K871933 MODEL 5050 SURGILASER FOR NEUROSURGERY USE Lasermatic, Inc. GEX Class II 1988-01-22
K875261 KIMBERLY-CLARK FULL COVERAGE HOOD Kimberly-Clark Corp. FYF Class I 1988-01-22
K875289 SUCTION RETRACTOR T. Korossurgical Instruments Corp. GAD Class I 1988-01-22
K875319 NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS I-Tech Industries, Inc. GEN Class I 1988-01-22
K873790 MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY Cooper Lasersonics, Inc. GEX Class II 1988-01-22
K875194 KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001 Welch Allyn, Inc. FXX Class II 1988-01-22
K874665 SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY Precision Dynamics Corp. LRP Class I 1988-01-20
K873731 SAFETY SHIELD KIT Ballard Medical Products FXX Class II 1988-01-15
K872453 DEBRISAN ABSORBENT PAD Pharmacia, Inc. KOZ Class I 1988-01-14
K875189 ULTRA TAN PURPLE MINT Ultra Tan Intl. AB LEJ Class II 1988-01-14
K874478 DYNAFILM Ferris Mfg. Corp. NAD Class I 1988-01-14
K875190 ULTRA TAN PURPLE PRO Ultra Tan Intl. AB LEJ Class II 1988-01-14
K875092 DEGANIA SILICONE TOURNIQUET Degania Silicone , Ltd. GAX Class I 1988-01-07
K874891 FLEXIE THE COPPER SHANK NEEDLE Skin Deep, Inc. KCW Class I 1988-01-07
K874296 INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER Ulti-Med Intl., Inc. FXX Class II 1988-01-07
K872823 DELTA SCRUB Pacific Biosystems, Inc. GEC Class I 1988-01-07
K873748 RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT Deknatel, Inc. GDW Class II 1988-01-06
K873443 ULTRASPOT MICROMANIPULATOR Cooper Lasersonics, Inc. GEX Class II 1988-01-06
K874950 MICROSURGICAL INSTRUMENTS Solway, Inc. HTD Class I 1987-12-30
K874965 MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE Solway, Inc. HTD Class I 1987-12-30
K874000 PRIA-KIT (TM) PRIAPISM KIT S.S. Canton Medical, Inc. GAA Class I 1987-12-30
K874959 VASCULAR CLAMP Solway, Inc. HXD Class I 1987-12-30

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