meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
31
Latest Decision
1991-10-04

Clearances · page 119 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K912952 BANDAGE COMPRESS Cal West Trading Co. NAB Class I 1991-10-04
K913700 DISPOSABLE BOUFFANT CAP Gem Nonwovews, Inc. FYF Class I 1991-10-04
K912457 MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO Medical Armor Corp. LYU Class I 1991-10-04
K911944 MEDI GUARD DENTAL BIB Sancella, Inc. KKX Class II 1991-10-04
K912950 COMPRESS DRESSING Cal West Trading Co. NAB Class I 1991-10-04
K912472 DEROYAL WOUND DRESSING Deroyal Industries, Inc. MGO Class I 1991-10-02
K912429 N80-838 SUPRAMID EXTRA SUTURE S. Jackson, Inc. GAR Class II 1991-10-02
K913402 PERRY(R) DERMAGUARD(R) PLUS GLOVES Smith & Nephew Perry KGO Class I 1991-10-02
K913047 STERILESERT(TM) CABLE AND POLE DRAPE Arch Development Group KKX Class II 1991-10-02
K912779 GAUZE SPONGE,STERILE 2'S Keilei Intl., Inc. NAB Class I 1991-09-30
K912953 GAUZE COMPRESS Cal West Trading Co. NAB Class I 1991-09-30
K913140 SILICONE GEL SHEETING Cui Corp. MDA Class I 1991-09-30
K914104 ENDOSTAT Laserscope GEX Class II 1991-09-27
K914131 WILTEK ELECTROCAUTERY ADAPTOR Wiltek Medical, Inc. GEI Class II 1991-09-25
K912968 ELEC SURG INSTR FOR LOPPROSCOPE CHOLECYSTECYOMY Paden Foudry , Ltd. GEI Class II 1991-09-25
K910037 COHERENT HOLMIUM:YAG SURGICAL LASER Coherent Medical Group GEX Class II 1991-09-25
K914132 WILTEK ELECTROCAUTERY ACTIVE CORD Wiltek Medical, Inc. GEI Class II 1991-09-25
K912229 IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 Dlp, Inc. GEI Class II 1991-09-25
K910027 CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO Biovision, Inc. GEX Class II 1991-09-25
K913918 HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER Heraeus Lasersonics, Inc. GEX Class II 1991-09-25
K913211 AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 1991-09-25
K912347 BIPURE 1000 Laser Engineering, Inc. FYD Class II 1991-09-23
K912478 SEVACARE STERILE SURGEON'S GLOVES Sevaids Industries KGO Class I 1991-09-23
K913215 SURGIFIT STERILE SURGICAL GLOVES Hevealactics Intl. Sdn Bhd KGO Class I 1991-09-23
K912947 STARPAC O.R. TOWEL Multi M Intl., Inc. KKX Class II 1991-09-23
K912790 SURGICAL GOWN Unicor Federal Dept. of Justice FYE Class I 1991-09-19
K911312 SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL Northgate Technologies, Inc. GEI Class II 1991-09-19
K913135 LM-300TWIN Leisegang Medical, Inc. FSW Class II 1991-09-18
K912793 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS) Surgical Laser Technologies, Inc. GEX Class II 1991-09-18
K912614 ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS Andrew Surgical GEI Class II 1991-09-18
K913155 LEG URINAL Ezmt Valve Co., Inc. GAQ Class II 1991-09-16
K913564 HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE Heraeus Lasersonics, Inc. GEX Class II 1991-09-16
K912656 ENDOSCOPIC ELECTRODE Applied Urology, Inc. GEI Class II 1991-09-16
K911131 STERILE SURGICAL GOWN PACK Central Georgia Ancillary Health Systems KKX Class II 1991-09-16
K912628 AIR ARGON ION LASERS VARIOUS MODELS Hgm Medical Laser Systems, Inc. GEX Class II 1991-09-13
K912645 ATRIUMS PDR THORACIC CATHETER Atrium Medical Corp. GBS Class I 1991-09-13
K913513 LATERALASE STERILE DISPOSABLE FIBER Heraeus Lasersonics, Inc. GEX Class II 1991-09-11
K913049 SLIP-PRUF-CLINGER Macbrud Corp. Medical Div. KDD Class I 1991-09-11
K913207 TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE Baxter Healthcare Corp KGO Class I 1991-09-11
K913488 STI CONTACT 200 FIBEROPTIC DELIVERY SYSTEM Sunrise Technologies, Inc. GEX Class II 1991-09-10
K912954 STRETCH GAUZE BANDAGE Cal West Trading Co. NAB Class I 1991-09-10
K912951 12-PLY GAUZE PAD Cal West Trading Co. NAB Class I 1991-09-10
K912182 MEDITRON COMBINATION GENERATOR CG-2000 Medical Devices, Inc. GEI Class II 1991-09-06
K912949 TRIANGULAR BANDAGE,40 Cal West Trading Co. NAB Class I 1991-09-06
K912597 ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. GEI Class II 1991-09-06
K913411 DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING Davis & Geck, Inc. GDW Class II 1991-09-06
K913036 PLUME MASTER Sorex Medical FYD Class II 1991-09-06
K912157 HYPOALLERGENIC SURGICAL LATEX GLOVES Medigloves , Ltd. KGO Class I 1991-09-06
K912538 KTP/YAG PLUS Laserscope GEX Class II 1991-09-06
K913037 SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS Sharplan Lasers, Inc. GEX Class II 1991-09-06
K913473 E-Z CLEAN ELECTRODE Megadyne Medical Products, Inc. GEI Class II 1991-09-06
K913139 IMPLANTABLE METAL STAPLES ETHICON, Inc. GDW Class II 1991-09-06
K911457 TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST Trimedyne, Inc. GEX Class II 1991-09-05
K911717 ADG INTRAMEDULLARY BONE PLUG - VENTED American Design Group, Inc. LZN Class II 1991-09-04
K904435 VENTROFIL TENSION RELIEF SUTURE SET Aesculap, Inc. KGS Class I 1991-08-29
K912792 SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER Sharplan Lasers, Inc. GEX Class II 1991-08-29
K912105 EYE TRAY Medical Device Inspection Co., Inc. LRP Class I 1991-08-29
K904873 STERILE SURGICAL PACK Angelica Healthcare Services KKX Class II 1991-08-29
K911334 MASK, SURGICAL APPAREL Thai Hospital Products Co., Ltd. FXX Class II 1991-08-29
K910889 ABC LAPAROSCOPIC HANDPROBE Birtcher Medical Systems, Inc. GEI Class II 1991-08-29
K912106 ARTHROSCOPY TRAY Medical Device Inspection Co., Inc. FSM Class I 1991-08-29
K912074 BONE MARROW BIOPSY TRAY Manan Medical Products, Inc. GAA Class I 1991-08-28
K912053 OPEN HEART TRAY Medical Device Inspection Co., Inc. FSM Class I 1991-08-26
K913043 MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS Tecnol New Jersey Wound Care, Inc. FXX Class II 1991-08-23
K912918 IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER Iriderm Div. GEX Class II 1991-08-23
K912332 MICROSURGE LASER FIBER HOLDER Microsurge, Inc. GEX Class II 1991-08-21
K912853 PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM) Precision Laser Products, Inc. FYD Class II 1991-08-20
K912052 HEART CATH TRAY Medical Device Inspection Co., Inc. FSM Class I 1991-08-20
K912284 BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF Douglas James Donaldson Compliance Services GEX Class II 1991-08-19
K910062 02-10,001 Laser Engineering, Inc. GEX Class II 1991-08-16
K913281 E-Z CLEAN LAPAROSCOPIC ELECTRODE Megadyne Medical Products, Inc. GEI Class II 1991-08-16
K912490 CITATION MEDICAL SCOPE PROCEDURE PACK Citation Medical Corp. KKX Class II 1991-08-16
K912337 ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS Megadyne Medical Products, Inc. GEI Class II 1991-08-16
K911830 LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER Laserscope GEX Class II 1991-08-14
K912029 ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER Coherent Medical Group GEX Class II 1991-08-13
K911987 LUXUS 132 ND: YAG SURGICAL LASER SYSTEM Heraeus Lasersonics, Inc. GEX Class II 1991-08-13
K912109 URESIL GENERAL PURPOSE DRAINAGE CATHETER Uresil Corp. GBO Class I 1991-08-12
K912422 SURG/ASSIST MODEL SA-1 Surg-Assist, Inc. FYD Class II 1991-08-12
K911565 CUSTOM PROCEDURE TRAY Vanguard Medical Concepts, Inc. KKX Class II 1991-08-09
K910272 HGM COMBINATION ND:YAG & SOLID STATE GREEN Hgm Medical Laser Systems, Inc. GEX Class II 1991-08-09
K912104 MAJOR BASIN TRAY Medical Device Inspection Co., Inc. FSM Class I 1991-08-09
K905125 GUARANTY HAIR REMOVAL SYSTEM Stephens Mfg. Co. KCX Class I 1991-08-05
K912022 FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES Fraass Survival Systems, Inc. NAD Class I 1991-08-02
K911520 ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE Andronic Devices, Ltd. KKX Class II 1991-08-02
K911521 ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP Andronic Devices, Ltd. KKX Class II 1991-08-02
K912237 STRYKER ECLIPSE WARMING STRETCHER Stryker Medical DWI Class I 1991-07-30
K903963 KITS AND TRAYS FOR ONE TIME USE ONLY Apk Technology LRP Class I 1991-07-29
K903962 INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE Apk Technology LRP Class I 1991-07-29
K911904 MODELS UES-10 & PSD-10 Olympus Corp. GEI Class II 1991-07-26
K911154 SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 Sun Medical, Inc. FYD Class II 1991-07-26
K903175 ADVANCE SUTURE NONABSORBABLE DACRON SUTURE Advance Suture, Inc. GAS Class II 1991-07-26
K912834 SHUR-GRIP Inman Medical Corp. KDC Class I 1991-07-26
K904723 FORCEPS Minto Research & Development, Inc. GEN Class I 1991-07-26
K911252 PRECISE BARND PI DISPOSABLE SURGICAL STAPLES 3M Medical Products Group GDW Class II 1991-07-25
K912110 DISPOSABLE O.R. TOWEL American Threshold Industries, Inc. KKX Class II 1991-07-25
K912542 PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS Puritas Health Care, Inc. KKX Class II 1991-07-23
K905752 ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE Beacon Laboratories, Inc. GEI Class II 1991-07-22
K910895 SURGICAL GLOVES Influx Pacific Sdn. Bhd. KGO Class I 1991-07-22
K912797 PERRY NATURAL POWDER FREE GLOVES Smith & Nephew, Inc. KGO Class I 1991-07-19
K912761 SURGICAL SAW BLADES Blairden Precision Instruments, Inc. GFA Class I 1991-07-19

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