meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
46
Latest Decision
1992-10-28

Clearances · page 115 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K921822 FRAY BIO-PUNCH Fray Products Corp. MDM Class I 1992-10-28
K913893 RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE Depuy, Inc. KGO Class I 1992-10-23
K922716 SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509 Splash Shield, Inc. FXX Class II 1992-10-23
K920568 STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL Border Opportunity Saver Systems, Inc. FYA Class II 1992-10-22
K922530 VISITEC MICROSURGICAL SUTURE Visitec Co. GAR Class II 1992-10-20
K922630 MOPYLEN S. Jackson, Inc. GAW Class II 1992-10-20
K920284 DRAPE UTILITY/SURGICAL STERILE DISPOSABLE Trinity Laboratories, Inc. KKX Class II 1992-10-19
K922625 ADEPT ENDOSCOPIC POSITIONER Andronic Devices, Ltd. GAD Class I 1992-10-19
K922626 ADEPT INSTRUMENT POSITIONING ACCESSORY Andronic Devices, Ltd. GAD Class I 1992-10-19
K920989 SURGICAL INSTRUMENT KIT, DISPOSABLE Ulti-Med Intl., Inc. KDD Class I 1992-10-19
K922785 IRRIVAGE Autovage EYF Class I 1992-10-16
K915415 GUARDALL SHIELD Anago, Inc. LYU Class I 1992-10-15
K923683 CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER Cynosure, Inc. GEX Class II 1992-10-15
K923332 ELECTROSURGICAL ELECTRODES Premier Dental Products Co. GEI Class II 1992-10-13
K920641 ALCON OPERATING MICROSCOPES Alcon Laboratories HRM Class I 1992-10-09
K922836 CHROMOPHARE Berchtold Holding GmbH FSY Class II 1992-10-09
K923378 USP TYPE VII GAUZE SPONGES E.W.A., Ltd. NAB Class I 1992-10-06
K923116 COMBINE II WETPROOF PAD Hermitage Hospital Products, Inc. NAB Class I 1992-10-06
K922769 STERILE SURGEONS GLOVES -- MODIFICATION Real Latex Pvt. , Ltd. KGO Class I 1992-10-06
K921300 MODEL PC ARGON ION LASER Hgm Medical Laser Systems, Inc. GEX Class II 1992-10-06
K920203 TECNOL INFECTION CONTROL MASK Tecnol Medical Products, Inc. FXX Class II 1992-10-05
K914193 A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT Alto Development Corp. GEI Class II 1992-10-05
K922509 LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA Everest Medical Corp. GEI Class II 1992-10-01
K921708 CYTOCARE LASER CATHETER FOR UROLOGY Cytocare, Inc. GEX Class II 1992-10-01
K921848 BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT Alm Surgical Equipment, Inc. FSQ Class II 1992-10-01
K920210 SRH-678 VACCUUM TUBING Quinn Healthcare Products FYD Class II 1992-10-01
K920209 CRF CHARCOAL CANISTER REPLACEMENT FILTER Quinn Healthcare Products FYD Class II 1992-10-01
K921049 SURGICAL DRAPE Amsco Sterile Recoveries, Inc. KKX Class II 1992-10-01
K922917 ENDOPROBES Endooptiks, Inc. GEX Class II 1992-09-28
K920763 LACERATTION TRAY Sterile Concepts, Inc. KDD Class I 1992-09-28
K922828 ULCER WOUND TRAY Ulti-Med Intl., Inc. KKX Class II 1992-09-28
K921424 SIL-MED FLAT SUCTION DRAIN Sil-Med Corp. GBX Class I 1992-09-28
K920001 HEMOLAB SILIMAT REAGENT Biomerieux Vitek, Inc. GFI Class I 1992-09-25
K924270 BREAST LESION LOCALIZATION NEEDLE Core Medical, Inc. GDF Class I 1992-09-23
K921664 BIO-GUARD LATEX SURGICAL GLOVES Network Medical Systems, Inc. KGO Class I 1992-09-23
K922523 BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS Ximed Medical Systems GEI Class II 1992-09-23
K923037 MILES SODIUM METHOD Heraeus Kulzer, Inc. JOS Class II 1992-09-22
K914678 ODYSSEY HO:YAG SURGICAL LASER SYSTEM Xintec Corporation GEX Class II 1992-09-21
K922462 NEXTEC FIBEROPTIC CABLES Nextec Corp. HBI Class II 1992-09-21
K922661 HHI PNEUMATIC ROTARY DRILL H&H Instruments HSZ Class I 1992-09-18
K922056 HHI ELECTRIC CONSOLE #875-000 H&H Instruments HWE Class I 1992-09-18
K921107 AUTOVAC Life Support Products, Inc. BTA Class II 1992-09-17
K922460 ORIGIN SECONDARY CANNULA AND TROCAR Origin Medsystems, Inc. GEA Class I 1992-09-16
K922895 J-VAC BULB SUCTION RESERVOIR Johnson & Johnson Medical, Inc. GCY Class I 1992-09-15
K923351 SKIN SUPPORT PREP PAD Coloplast Corp. KOX Class I 1992-09-14
K920510 URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER Uresil Corp. GAR Class II 1992-09-14
K922874 DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE Supra Instruments, Inc. MDM Class I 1992-09-11
K921143 PNEUMO-WEDGE Kansas Creative Devices, Inc. FQO Class I 1992-09-11
K924264 O.R. CONCEPTS CABLE HARNESS O.R. Concepts, Inc. GEI Class II 1992-09-11
K920296 DISPOSABLE FORCEPS Falcon Instruments, Inc. MDM Class I 1992-09-11
K920297 DISPOSABLE SCISSORS Falcon Instruments, Inc. MDM Class I 1992-09-11
K923846 BURN DRESSING Medical Action Industries, Inc. NAB Class I 1992-09-11
K923689 SURGISTAR BLADES Surgistar, Inc. GDX Class I 1992-09-09
K921611 MADAVAC 190 Mada Medical Products, Inc. BTA Class II 1992-09-09
K915296 MONOPOLAR ELECTRODE Lifeguard Medical Products, Inc. GEI Class II 1992-09-03
K922279 ILLUMINATOR IV MINOR SURGERY LIGHT Medical Illumination, Inc. FSW Class II 1992-09-02
K922963 TL100W/12 Philips Lighting Co. FTC Class II 1992-09-02
K913990 KTP/532 & KTP/YAG Laserscope GEX Class II 1992-09-02
K922002 SUCTION IRRIGATION CAUTERY PROBE Megadyne Medical Products, Inc. GEI Class II 1992-09-02
K922489 MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA Porex Technologies Corp. FWP Class II 1992-09-02
K922878 MODEL GT1ST CRYOSURGICAL INSTRUMENT Gyne-Tech Instrument Corp. GEH Class II 1992-09-02
K922820 WOODBINE XT350, XENON ARC LIGHT SOURCE Woodbine Ptical Corp. FST Class II 1992-09-02
K920846 CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER Trinity Laboratories, Inc. FXX Class II 1992-09-01
K923119 WALLSTENT ESOPHAGEAL PROTHESIS Schneider U.S. Stent Div. ESW Class II 1992-09-01
K923120 MICROGUIDE LESION MARKING SYSTEM Angiodynamics, Div. E-Z-Em, Inc. GDF Class I 1992-09-01
K922916 BARD MARLEX MESH DART C.R. Bard, Inc. FTL Class II 1992-08-24
K920405 STERILE SURGEON'S GOWN Amsco Sterile Recoveries, Inc. FYA Class II 1992-08-18
K920404 SURGEON'S GOWN Amsco Sterile Recoveries, Inc. FYC Class II 1992-08-18
K920518 E.R. SUTURE TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. KKX Class II 1992-08-17
K921921 CATHETER CHOLANGIOGRAPHY Laparomed Corp. GEI Class II 1992-08-17
K914097 SAFEMED LATEX SURGICAL GLOVES Safetytech Sdn. Bhd. KGO Class I 1992-08-14
K921843 CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER Cynosure, Inc. GEX Class II 1992-08-14
K915867 SOLCOVAC WOUND DRAINAGE SYSTEM Solco Basle, Inc. GCY Class I 1992-08-14
K921204 DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. KKX Class II 1992-08-13
K920673 PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT Percudisc, Inc. GEX Class II 1992-08-13
K921203 INCISSION & DRAINAGE TRAY Trinity Laboratories, Inc. KKX Class II 1992-08-13
K921394 DRESSING CHANGE TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. KKX Class II 1992-08-13
K913101 PETERS CARDIOFLON(TM) SUTURE Promedica Products, Inc. GAS Class II 1992-08-12
K920371 HPM REPLACEMENT ULPA FILTER MODEL UF001 Hpm Ent. FYD Class II 1992-08-12
K922234 DYNASTY ISOLATION GOWN Dynatech Medical Products FYC Class II 1992-08-11
K922663 IRIS OCULIGHT SL Iriderm Div. GEX Class II 1992-08-11
K920298 DISPOSABLE HEMOSTATS Falcon Instruments, Inc. HRQ Class I 1992-08-11
K920948 TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER Topox Therapeuutic Rentals, Inc. KPJ Class II 1992-08-11
K921058 DISPOSABLE ISOLATION GOWN Nat'L Surtex Corp. FYC Class II 1992-08-11
K922054 STERILE GAUZE SPONGES X-RAY DETECTABLE Team Mfg., Inc. GDY Class I 1992-08-10
K922544 MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE Kirschner Medical Corp. FST Class II 1992-08-07
K920355 SPECIALTY SPONGES Ultracell Medical Technologies, Inc. GDY Class I 1992-08-06
K922739 HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE Hollister, Inc. GBX Class I 1992-08-06
K920356 SURGICAL SPONGES Ultracell Medical Technologies, Inc. GDY Class I 1992-08-06
K922186 HEM-O-LOK -- MODIFICATION Linvatec Corp. GDW Class II 1992-08-06
K913303 LAP SPONGES, MODIFIED Carwild Corp. GDY Class I 1992-08-06
K920752 ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER ETHICON, Inc. GDW Class II 1992-08-06
K923028 TURKEL PNEUMOTHORAX KIT Symbiosis Corp. GCB Class I 1992-08-04
K921350 QUALTEX TUBE/CORD ORGANIZER Deroyal Industries, Inc. KKX Class II 1992-08-04
K922090 FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION Valleylab, Inc. GEI Class II 1992-08-04
K921841 CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER Cynosure, Inc. GEX Class II 1992-08-04
K923050 ND:YAG LASER-12 Laser Endo Technic GEX Class II 1992-08-03
K913102 PETERS CARDIONYL(TM) SUTURE Promedica Products, Inc. GAR Class II 1992-08-03
K921167 ULTRABLADE Micron Technology, Inc. GDX Class I 1992-07-30
K922354 BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET Med Institute, Inc. GCC Class I 1992-07-30

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