meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
52
Latest Decision
1984-08-10

Clearances · page 147 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842575 ULTRA-VIOLET A SOURCE LIGHT EMITTING Sola-Tan Intl. FTC Class II 1984-08-10
K842106 LEE BONE MARROW NEEDLES Southland Instruments, Inc. GAA Class I 1984-08-10
K842204 DMI ASPIRATOR 500 Dean Medical Instruments, Inc. BTA Class II 1984-08-10
K841869 COOPER LASERSONICS, 8000 ND.YAGLASER Cooper Lasersonics, Inc. LNK Class II 1984-08-08
K842384 ULTRA-VIOLET EMITTING SUNLAMP PRODUCT Sola-Tan Intl. FTC Class II 1984-08-08
K842050 IMPACT MODEL 316 Impact Instrumentation, Inc. JCX Class II 1984-08-03
K842822 CHERMEL BONE GOUGES Cher Mel Corp. GDH Class I 1984-08-02
K842701 HOPPENSTEIN MICROSURGICAL SPINAL INSTRU Downs Surgical , Ltd. FZS Class I 1984-08-02
K841735 ACU-DERM TRANSPARENT INCISE DRAPE Acme United Corp. KKX Class II 1984-08-02
K842699 ISLAM BONE MARROW ASPIRATION NEEDLES Downs Surgical , Ltd. GAA Class I 1984-08-02
K842702 ROSENBERG SKIN GRAFTING KNIVES Downs Surgical , Ltd. GFD Class I 1984-08-02
K841362 TIDAL DISTENSION IRRIGATION SET Abbott Laboratories GBX Class I 1984-08-02
K842824 CHERMEL BONE CHISELS Cher Mel Corp. KDG Class I 1984-08-02
K842823 CHERMEL OSTEOTOMES Cher Mel Corp. GFI Class I 1984-08-02
K842704 MT-700 MT-750 FT-350 Cryomedics, Inc. GEH Class II 1984-08-01
K842545 ALL-HANDS STERILE FIELD-0201 All-Hands Medical Supply, Inc. KKX Class II 1984-08-01
K842774 CODMAN SUCTION PUNCH-PRODUCT CODES Codman & Shurtleff, Inc. HTZ Class I 1984-07-27
K840370 SURG-A-STAT VASECTOMY TIP Suncoast Medical Manufacturers, Inc. GET Class I 1984-07-23
K842030 NEUTRAL POS-CHAIR SURGEON CHAIR Neutral Pos-Chair Co. FZK Class I 1984-07-23
K840387 SURG-A-STAT LOOP TIP 2 Suncoast Medical Manufacturers, Inc. GEI Class II 1984-07-23
K831632 MEDICAL RUBBER GLOVES-STERILE-SURGEONS Tagum Rubber Industries, Ltd. KGO Class I 1984-07-23
K840375 SURG-A-STAT LOOP TIP 15 Suncoast Medical Manufacturers, Inc. GEI Class II 1984-07-23
K841741 SINGLE HAIR TRANSPLANT GRAFT Paris Products, Inc. FZT Class I 1984-07-23
K840377 SURG-A-STAT CARDIOVASCULAR TIP Suncoast Medical Manufacturers, Inc. GEI Class II 1984-07-23
K841399 BRONCHOSCOPE SUCTION UNIT Keymed, Inc. BTA Class II 1984-07-18
K831148 HIGH FILTRATION ISO-MASK Tecnol New Jersey Wound Care, Inc. FXX Class II 1984-07-17
K841559 CONFORMA Beiersdorf, Inc. GBI Class I 1984-07-17
K841558 BANANA CUFF Aspen Laboratories, Inc. KCY Class I 1984-07-16
K841619 DRILL GUIDE Plastafil, Inc. FZX Class I 1984-07-11
K841234 HALO CO LASER SYSTEM Directed Energy, Inc. GEX Class II 1984-07-09
K840172 VENTRAL WALL DEFECT REDUCT SILO American Heyer Schulte FTL Class II 1984-06-27
K841979 4MM CUP CURRETTE Stainless Mfg., Inc. HTF Class I 1984-06-19
K841977 5MM DOUGLE EDGE RING CURETTE Stainless Mfg., Inc. HTZ Class I 1984-06-19
K841972 BANANA KNIFE - K841969-LABELING Stainless Mfg., Inc. HTZ Class I 1984-06-19
K841978 LATERAL RELEASE KNIFE 5MM & 7MM Stainless Mfg., Inc. HTZ Class I 1984-06-19
K841973 BANANA KNIFE SERRATED Stainless Mfg., Inc. HTZ Class I 1984-06-19
K841975 ROSETTE KNIFE 4MM Stainless Mfg., Inc. HTZ Class I 1984-06-19
K842111 KOGAN ENDOSPECULUM 9-1/2 J. Sklar Mfg. Co., Inc. HTZ Class I 1984-06-19
K841974 RETROGRADE KNIFE 4MM & 5MM Stainless Mfg., Inc. HTZ Class I 1984-06-19
K841982 MENISCOTOME 4MM & 5MM Stainless Mfg., Inc. HTZ Class I 1984-06-19
K841976 HOOK KNIFE 4MM & 5MM Stainless Mfg., Inc. HTZ Class I 1984-06-19
K841903 FRASER HARLAKE EMERG. CARE SUCTION SYS Fraser Harlake, Inc. BTA Class II 1984-06-14
K841538 IMPACT MODEL 308 Impact Instrumentation, Inc. JCX Class II 1984-06-11
K841085 SCANLAN COLORMARK SKIN MARKER Scanlan Intl., Inc. FZZ Class I 1984-06-11
K841677 STERILE BLOOD LANCETS Abco Dealers, Inc. FMK Class II 1984-06-11
K842115 SPUNGARD & SURG. DRAPES-GOWNS & PACKS Kimberly-Clark Corp. KKX Class II 1984-06-11
K841008 BIOPSY PUNCH, VARIOUS Premier Dental Products Co. GEE Class I 1984-06-08
K840957 ANTIMICROBIAL INCISE DRAPE American Convertors Div., American Pharmaseal KKX Class II 1984-06-07
K841514 SCANLAN VASCU-STATT II APPROXIMATOR Scanlan Intl., Inc. HRQ Class I 1984-06-05
K841301 GARDNER TYPE BONE MARROW NEEDLE Popper & Sons, Inc. GAA Class I 1984-06-05
K841165 ELECTRO SURGERY SYSTEM Micro-Aire Surgical Instruments, Inc. GEY Class I 1984-06-05
K841883 SURGEON'S BLADES STERILE BLADE An-Med Intl. GES Class I 1984-06-05
K841249 SUCTION CANNULAS Custom Surgical Products, Inc. GEA Class I 1984-06-04
K841160 MORWEL ASPIRATOR Morwel Corp. JCX Class II 1984-05-31
K840976 VARIOUS DISPOSABLE KITS/TRAYS/INSTRU Carapace, Inc. FSM Class I 1984-05-31
K833720 TRANSTHORACIC/TRANSABDOMINAL-TRAY Applied Medical Devices, Inc. GDM Class I 1984-05-30
K834367 SUTURE REMOVAL WOUND CLOSURE-INSTRU- Sterling Multi-Products, Inc. HTD Class I 1984-05-30
K831117 MICROMAT W/VARIOUS MODELS Pmt, Inc. FNW Class II 1984-05-30
K832138 BIOMER * PLEDGET SUTURE BUTTRESS ETHICON, Inc. KGS Class I 1984-05-23
K841183 SODIUM CHLORIDE SOLUTION BLOOD CELL Reagent Laboratory, Inc. FNW Class II 1984-05-21
K840803 GRAMS ASPIRATOR S-300 Grams Medical, Inc. BTA Class II 1984-05-21
K840142 YAG LASER 8000 - LOWER GI APPLICAT Cooper Lasersonics, Inc. LNK Class II 1984-05-18
K841614 SUN BEDS Sunworld Corp. FTC Class II 1984-05-16
K832283 MEDPAR SURGICAL IMPLANTS Porex Medical FWP Class II 1984-05-10
K841116 MOBILE OPHTHALMIC OPERATING TABLE Surgi-Quip Inc.U FWX Class I 1984-05-09
K841115 CHARLES/MCINTYRE GIANT BREAK TABLE Surgi-Quip Inc.U FQO Class I 1984-05-09
K841299 BIERMAN BIOPSY NEEDLE Popper & Sons, Inc. GDM Class I 1984-05-02
K841247 SPC DISPOSABLE CUTTER Surgical Products Corp. FZT Class I 1984-05-02
K840304 CATEGORY 17-MICROBIOLOGY DEVICES Imm Enterprises , Ltd. HTD Class I 1984-05-01
K841009 SURGICAL RETRACTORS-VARIOUS Premier Dental Products Co. GAD Class I 1984-05-01
K841010 SURGICAL HOOKS, VARIOUS Premier Dental Products Co. GDG Class I 1984-05-01
K834332 BOUNDARY SINGLE-USE GOWNS Procter & Gamble Mfg. Co. FYA Class II 1984-05-01
K834135 STERILE SUTURE BOOTS Devon Industries, Inc. KDD Class I 1984-04-27
K841298 HOLE CHAMFERING DEVICE Techmedica, Inc. GFF Class I 1984-04-25
K840434 REPLACE-A-TIP LOW TEMP. CAUTERY Suncoast Medical Manufacturers, Inc. GEI Class II 1984-04-25
K840980 HALF ROUND FILE Med-Tool, Inc. HTC Class I 1984-04-25
K840433 REPLACE-A-TIP HIGH TEMP. CAUTERY Suncoast Medical Manufacturers, Inc. GEI Class II 1984-04-25
K840931 SUN BEDS Wakewood Sunbeds FTC Class II 1984-04-25
K841297 TECHMEDICA DRILL GUIDE Techmedica, Inc. FZX Class I 1984-04-25
K840323 SILICONE SUCTION & IRRIGATION DRAIN Superior Plastic Products Corp. GBX Class I 1984-04-25
K834434 MACH I ELECTROSURGERY HAND CONTROL Surgical Products Corp. GEI Class II 1984-04-25
K840820 SECURLINE SURGICAL SKIN MARKER 1000 Precision Dynamics Corp. FZZ Class I 1984-04-25
K840324 SILICONE SUMP DRAIN 20 & 40 FRENCH Superior Plastic Products Corp. JCY Class I 1984-04-25
K832550 SHARPLAN #734 LASER SURGICAL UNIT Laser Industries , Ltd. GEX Class II 1984-04-25
K840978 TOGGLE LOCKING PLIER Med-Tool, Inc. HTC Class I 1984-04-25
K841171 TRILICON BREASE PROSTHESIS DIFFERENT Baurs Krey Assoc., Inc. GBI Class I 1984-04-25
K841122 TRACHEOSTOMY CARE TRAY Medcare Products FSM Class I 1984-04-25
K840206 PRESSURE SENTRY TOURNIQUET Richards Medical Co., Inc. KCY Class I 1984-04-25
K840817 DISPOSABLE, HYPERBARIC OXYGEN CHAMBER Hospitak, Inc. KPJ Class II 1984-04-25
K840979 SLIP JOINT PLIER Med-Tool, Inc. HTC Class I 1984-04-25
K840372 FLEXIBLE ILLUMINATOR 15 Suncoast Medical Manufacturers, Inc. FTF Class II 1984-04-24
K840132 TANSEEKER Senator Leisure Products, Ltd. FTC Class II 1984-04-24
K840158 KOSMEDICO GMBH SUNLAMP PRODUCTS Kosmedico, Kosmetische & Medizinisch FTC Class II 1984-04-24
K840371 FLEXIBLE ILLUMINATOR 5 Suncoast Medical Manufacturers, Inc. FTF Class II 1984-04-24
K840373 FLEXIBLE ILLUMINATOR 10 Suncoast Medical Manufacturers, Inc. FTF Class II 1984-04-24
K841320 PERCUTANEOUS TRIG. FINGER RELEASE KNIFE Anapach Effort, Inc. GES Class I 1984-04-24
K840133 ULTRAVIOLET TANNING SYSTEMS Merrittan Sunfun, Inc. FTC Class II 1984-04-24
K841360 MINOR SURGICAL LIGHT MODEL 180 American Sterilizer Co. FTD Class II 1984-04-24
K840913 PROVAC WOUND DRAINAGE & HEALING SYS Meyer Medical U.S.A., Inc. GCY Class I 1984-04-24
K840922 INTRADISCAL THERAPY NEEDLE 18 GAUGE Dlp, Inc. GAA Class I 1984-04-24

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