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
1990-11-21

Clearances · page 123 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K902996 ARGON BEAM LAPAROSCOPIC ELECTRODE Beacon Laboratories, Inc. GEI Class II 1990-11-21
K904746 S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER Joint Medical Products Corp. JDK Class II 1990-11-20
K904478 NONABSORBABLE SILK SURGICAL SUTURE United States Surgical, A Division of Tyco Healthc GAP Class II 1990-11-14
K904891 NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE) United States Surgical, A Division of Tyco Healthc GAP Class II 1990-11-14
K904067 LASERSAT CO2 Satelec GEX Class II 1990-11-07
K904320 STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX) R.K.F. Laboratories, Inc. KGO Class I 1990-11-07
K903649 BRADLEY TENACULUM HOLDER Marlo Surgical Technology KDC Class I 1990-11-02
K904085 ELLA BREAST FORM Coloplast A/S KCZ Class I 1990-10-31
K901705 CUSTOMED CYSTO PACK II Customed, Inc. KKX Class II 1990-10-31
K903747 ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U Downs Surgical , Ltd. GDM Class I 1990-10-31
K903748 ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V Downs Surgical , Ltd. GDM Class I 1990-10-31
K904826 TKO TELESCOPING LITHOTOMY STIRRUP D.L. Nelson and Assoc., Inc. FWZ Class I 1990-10-31
K904218 SUCTION SYSTEM Axiom Medical, Inc. GEA Class I 1990-10-31
K903750 ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E Downs Surgical , Ltd. GDM Class I 1990-10-31
K902191 CUSTOMED LAP PACK II Customed, Inc. KKX Class II 1990-10-31
K903749 ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U Downs Surgical , Ltd. GDM Class I 1990-10-31
K904112 STI DRAPE SHEET STYLE 1908 Sterilizer Technologies Corp. KKX Class II 1990-10-30
K904126 VISIRASER Acorn Group, Inc. GEX Class II 1990-10-30
K904578 MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP United States Surgical, A Division of Tyco Healthc GET Class I 1990-10-30
K903709 SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH Lifestream Int'L, Inc. GBZ Class I 1990-10-26
K903908 REPAK SURGICAL PACKS Repack Surgical Enterprises, Inc. KKX Class II 1990-10-26
K903936 SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST Surgical Laser Technologies, Inc. GEX Class II 1990-10-26
K904052 SUPRAMID EXTRA SUTURES S. Jackson, Inc. GAR Class II 1990-10-25
K903029 STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE Look, Inc. GAR Class II 1990-10-25
K903486 MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 Pennsylvania Association For the Blind FXX Class II 1990-10-23
K904412 ALLEVYN DRESSING CLAIMS CHANGE Smith & Nephew United, Inc. KOZ Class I 1990-10-23
K903533 STERI-SHIELD Biomedical Devices, Inc. FXY Class II 1990-10-19
K903610 O.R. TIP CLEANER Inman Liebelt Corp. GEI Class II 1990-10-19
K904162 CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES Norco, Inc. GEX Class II 1990-10-19
K904263 DACRON R SURGICAL SUTURES Sharppoint, Inc. GAS Class II 1990-10-16
K904133 DISPOSABLE FLUID COLLECTION BAG Axiom Medical, Inc. GBX Class I 1990-10-11
K904316 NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT Coloplast Corp. KCZ Class I 1990-10-11
K903987 TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED Baxter Healthcare Corp KGO Class I 1990-10-11
K903444 MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG Heraeus Lasersonics, Inc. GEX Class II 1990-10-11
K903230 SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075 Sharplan Lasers, Inc. GEX Class II 1990-10-11
K903584 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES Look, Inc. GAW Class II 1990-10-11
K903127 SURGITEK(R) TURP MONITOR Surgitek Medical Engineering Corp. GEI Class II 1990-10-09
K904015 ELECTRO-BLEND EPILATOR, MODEL UC-3 A.R. Hinkel Co., Inc. KCW Class I 1990-10-04
K903079 ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM) Luxar Corp. GEX Class II 1990-10-04
K900858 CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES Candela Laser Corp. GEX Class II 1990-10-03
K904054 POLYVIOLENE(TM) SUTURE Look, Inc. GAS Class II 1990-10-03
K902939 OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM Trimedyne, Inc. GEX Class II 1990-10-03
K902940 CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM Trimedyne, Inc. GEX Class II 1990-10-03
K902946 PEGASUS W/ACCESSORIES FOR GENERAL SURGERY Pfizer Laser Systems GEX Class II 1990-10-02
K903302 ELECTRODE, ELECTROSURGERY Megadyne Medical Products, Inc. JOS Class II 1990-10-02
K904136 SUTURE TENSION ADJUSTMENT REEL Surgical Systems, Inc. KGS Class I 1990-10-02
K902133 MODEL IS102S ND:YAG SURGICAL LASER SYSTEM Niic U.S.A., Inc. GEX Class II 1990-10-02
K902947 PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION Pfizer Laser Systems GEX Class II 1990-10-02
K904086 DISCRENE SELF-SUPPORTING BREAST FORM Coloplast A/S KCZ Class I 1990-10-02
K903027 PEGASUS WITH ACCESSORIES Pfizer Laser Systems GEX Class II 1990-10-02
K902990 COHERENT HOLMIUM:YAG SURGICAL LASER Coherent Medical Division GEX Class II 1990-10-02
K903446 COMFIT SURGEON'S GLOVES Wembley Rubber Products (M) Sdn Bhd KGO Class I 1990-10-01
K903724 BEAMER 1,2,4,6, AND 8 Beacon Laboratories, Inc. GEI Class II 1990-09-28
K902715 SURGICAL TOWEL Aztec Medical, Inc. KKX Class II 1990-09-28
K902872 NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE* United States Surgical, A Division of Tyco Healthc GAW Class II 1990-09-27
K902873 NONABSORBABLE DACRON SURGICAL SUTURE* United States Surgical, A Division of Tyco Healthc GAS Class II 1990-09-27
K902534 CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER Pfizer Laser Systems GEX Class II 1990-09-25
K902871 OPTILITE FIBEROPTIC DELIVERY SYSTEMS Xintec Corporation GEX Class II 1990-09-24
K903288 IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED Iriderm Div. GEX Class II 1990-09-24
K903689 COHERENT DIODE PHOTOCOAGULATOR Lumenis, Inc. GEX Class II 1990-09-20
K903006 ELECTROSURGICAL BIPOLAR FORCEPS Megadyne Medical Products, Inc. GEI Class II 1990-09-20
K902763 STERILE INSTRUMENT DRAPE North American Sterilization & Packaging Co. HMW Class II 1990-09-20
K901710 OPTICA 120 ND:YAG SURGICAL LASER SYSTEM Xintec Corporation GEX Class II 1990-09-20
K903412 STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. Storz Instrument Co. EPT Class I 1990-09-20
K903812 ELECTROPROBE SINGLE-USE SURGICAL PROBE Ximed Medical Systems GEI Class II 1990-09-20
K902886 CUSTOMED BASIC PACK III Customed, Inc. KKX Class II 1990-09-19
K902885 CUSTOMED BASIC PACK II Customed, Inc. KKX Class II 1990-09-19
K902714 LATEX SURGICAL GLOVES (YUETONG ENTERPRISE CO. LTD) Quinhuangda Yuetong Ent. Co., Ltd. KGO Class I 1990-09-19
K902884 CUSTOMED BASIC PACK I Customed, Inc. KKX Class II 1990-09-19
K903883 VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES Metatech Corp. GEX Class II 1990-09-19
K903624 PLAIN AND CHROMIC GUT SUTURE Look, Inc. GAL Class II 1990-09-18
K903713 OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 Micro-Aire Surgical Instruments, Inc. HSZ Class I 1990-09-14
K903650 OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 Micro-Aire Surgical Instruments, Inc. HWE Class I 1990-09-14
K901991 SILICONE ELASTOMER PUTTY Crown Delta Corp. MDA Class I 1990-09-14
K901990 VINYL SILICONE ELASTOMER MATERIAL Crown Delta Corp. MDA Class I 1990-09-14
K903513 SANOFLEX-STERILE LATEX SURGICAL GLOVES Lowenkamp Intl., Inc. KGO Class I 1990-09-14
K902285 THE MAGNUM CHIN IMPLANT Applied Biomaterial Technologies FWP Class II 1990-09-12
K902284 ZYMALAR IMPLANT Applied Biomaterial Technologies LZK Class II 1990-09-12
K902615 ADG BONE PLUG American Design Group, Inc. LZN Class II 1990-09-11
K903327 CUI ARTICULATED SILICONE CHIN Cui Corp. FWP Class II 1990-09-10
K901127 LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY Lasercomp GEX Class II 1990-09-10
K900925 NIDEK, INC. MODEL ADC-8000 DERM Nidek, Inc. GEX Class II 1990-09-10
K903328 CUI PREMAXILLARY IMPLANT Cui Corp. FZE Class II 1990-09-10
K902851 MICROSCOPE DRAPE Medical Technique Instruments, Inc. HMW Class II 1990-09-10
K902888 CUSTOMED ORTHOPEDIC II Customed, Inc. LRO Class II 1990-09-10
K902864 SURGICAL LIGHTING-CENTRA 450 Sds Dental, Inc. FSY Class II 1990-09-10
K900890 NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA Nidek, Inc. GEX Class II 1990-09-10
K902865 BAUMER SURGICAL TABLE Sds Dental, Inc. BWN Class I 1990-09-10
K903329 CUI ANATOMICAL SILICONE MALAR Cui Corp. LZK Class II 1990-09-10
K902887 CUSTOMED ARTHROSCOPY PACK Customed, Inc. LRO Class II 1990-09-10
K902731 ENDOSCOPIC HEMOSTATIC LIGATING LOOP United States Surgical, A Division of Tyco Healthc GAL Class II 1990-09-07
K903855 THE ON-GARD CORD-CADDY On-Gard Systems, Inc. GEI Class II 1990-09-07
K900425 SURGICAL COTTON GLOVES Allo Pro Corp. LYU Class I 1990-09-07
K902348 SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* Futuristic Medical Concepts, Inc. FYA Class II 1990-09-06
K903849 MODEL RD-1200 RUBY LASER SYSTEM Charles L. Rose and Co., Inc. GEX Class II 1990-09-05
K902546 THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK Anago, Inc. FXX Class II 1990-09-05
K902547 THE PROTECTOR II, LASER SURGICAL MASK Anago, Inc. FXX Class II 1990-09-05
K903969 SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET Karlin Technology, Inc. GAD Class I 1990-09-05
K902349 SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER Surgitek FZW Class I 1990-09-05
K902177 MANAN BONE BIOPSY NEEDLE Manan Medical Products, Inc. GDM Class I 1990-09-05

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