meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
2013-07-23

Clearances · page 32 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K123807 SHARPSCAN Medical Engineering Development Solutions, Inc. MMK Class II 2013-07-23
K131358 BD PEN NEEDLE Becton, Dickinson & CO FMI Class II 2013-07-16
K131120 AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation MLR Class II 2013-07-16
K122402 LPP (LOW PROFILE PORT) Pfm Medical, Inc. LJT Class II 2013-07-16
K131040 EXTAVIPRO STERICAN 30G B.Braun Melsungen AG FMI Class II 2013-07-15
DEN110006 VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR STERIS Corporation OWP Class II 2013-07-12
K131087 SHARPSTANK REUSABLE SHARPS CONTAINER Rehrig Pacific Company MMK Class II 2013-07-12
K131496 BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) Bsn Medical, Inc. DWL Class II 2013-07-10
K131338 DERMA HOOD Globalmedia Group, LLC PEQ Class I 2013-07-10
K130879 NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS Nexus Medical, LLC FPA Class II 2013-07-09
K131078 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation MED Class II 2013-07-05
K123234 ERMIS STERILIZATION CONTAINER SYSTEM Ermis Medizintechnik KCT Class II 2013-07-05
K131125 CLICKFINE PEN NEEDLE Ypsomed AG FMI Class II 2013-07-05
K130473 NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) Hartalega Sdn Bhd LZA Class I 2013-07-05
K131123 CLICKFINE AUTOPROTECT PEN NEEDLE Ypsomed AG FMI Class II 2013-07-05
K130211 AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS Spsmedical Supply Corp. JOJ Class II 2013-07-05
K130487 FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE Pyng Medical Corp. FMI Class II 2013-06-25
K131524 PROTEUS PATCH INCLUDING INGESTIBLE SENSOR Proteus Digital Health, Inc. OZW Class II 2013-06-23
K130281 OAK RIDGE PRODUCTS SHARP CONTAINER Oak Ridge Products, LLC MMK Class II 2013-06-21
K130927 DURABLUE STERILIZATION WRAP Cardinal Health200, LLC FRG Class II 2013-06-18
K123590 VINYL EXAMINATION POWDER FREE GLOVES, CLEAR Weilin Plastic and Rubber Products Co., Ltd. LYZ Class I 2013-06-17
K130867 ENFLOW IV FLUID WARMER INSULATED STRAP Vital Signs, Inc., A GE Healthcare Company LGZ Class II 2013-06-14
K122449 ENTERAL NUTRITION WARMER Acacia, Inc. LGZ Class II 2013-06-13
K130690 Z-800 INFUSION SYSTEM Zyno Medical, LLC FRN Class II 2013-06-12
K130416 NEXUS TKO-6P LUER ACTIVATED DEVICE Nexus Medical, LLC FPA Class II 2013-06-12
K130507 FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER Footprint Medical, Inc. LJS Class II 2013-06-03
K130532 IDRIVE ULTRA STERILIZATION TRAY Covidien, Formerly US Surgical A Divison of Tyco H KCT Class II 2013-05-30
K121898 STAY FRESH SKIN FOLD MANAGEMENT TEXTILE Quick-Med Technologies, Inc. FRL Class I 2013-05-24
K122978 SANICLAVE 102, MODEL RS-SC-102 Alternative Pioneering Research and Development FLE Class II 2013-05-23
K123937 ATOM TRANSCAPSULE V-707 Atom Medical Corporation FPL Class II 2013-05-23
K123084 DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD Elcam Medical Acal FMG Class II 2013-05-23
K122625 GETINGE 800HC- SERIES STEAM STERILIZER Getinge Sourcing, LLC FLE Class II 2013-05-22
K120671 DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) Cotronic Technology Limited FLL Class II 2013-05-17
K123617 3F PRO-PICC Medical Components, Inc. LJS Class II 2013-05-15
K123710 UNITOX BOTOX SYRINGE Bio-Med USA, Inc. FMF Class II 2013-05-09
K131038 NMI PICC MAXIMAL BARRIER NURSING KITS Navilyst Medical, Inc. LJS Class II 2013-05-09
K122774 SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG Sakura Seiki Co., Ltd. FLE Class II 2013-05-09
K123684 SOL-CARE SAFETY NEEDLE Sol-Millennium Medical FMI Class II 2013-05-08
K123368 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT Hartalega Sdn Bhd LYY Class I 2013-05-07
K131009 PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) Proteus Digital Health, Inc. OZW Class II 2013-05-07
K122404 MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 Repro-Med Systems, Inc. Dba Rms Medical Products FPA Class II 2013-05-06
K122416 ARTIGLASS L. O.R. GLASS SYRINGE Artiglass Srl FMF Class II 2013-05-03
K120532 GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM Getinge Sourcing, LLC PEC Class II 2013-05-02
K121613 AGILIA INFUSION SYSTEM Fresenius Kabi AG FRN Class II 2013-05-01
K122767 NMI PORT Navilyst Medical, Inc. LJT Class II 2013-04-30
K130518 MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER Luther Needlesafe Products, Inc. FOZ Class II 2013-04-30
K122945 STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 Steritec Products Mfg Co, Inc. JOJ Class II 2013-04-30
K130876 CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc. LJS Class II 2013-04-26
K122485 ENCIRCLE COMPRESSION THERAPY STOCKING Encircle Medical Devices , Ltd. DWL Class II 2013-04-23
K130725 MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. Covidien Lp, Formerly Registered AS Kendall FOS Class II 2013-04-17
K122464 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE Industrial Clothings, Ltd. LZA Class I 2013-04-12
K122453 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY Industrial Clothings, Ltd. LZA Class I 2013-04-05
K130023 K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR Np Medical, Inc. FPA Class II 2013-04-03
K123820 BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS Bossong Hosiery Mills, Inc. DWL Class II 2013-04-02
K130576 CELSITE IMPLANTABLE ACCESS PORT SYSTEMS B. Braun Interventional Systems, Inc. LJT Class II 2013-04-02
K130361 THERMOFINDER; THERMOCARE Hubdic Co., Ltd. FLL Class II 2013-04-02
K122221 NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER Taidoc Technology Corporation FLL Class II 2013-03-29
K123743 ULTRASAFE PLUS PASSIVE NEEDLE GUARD Safety Syringes, Inc. MEG Class II 2013-03-26
K122362 SMART-WELL INCUBATOR Mesa Laboratories, Inc. FRC Class II 2013-03-26
K130468 ORBIT INFUSION SET Ypsomed AG FPA Class II 2013-03-19
K123546 3M ATTEST(TM) AUTO-READER 3M Company FRC Class II 2013-03-18
K121593 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK 3M Company FRC Class II 2013-03-15
K124053 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. FRN Class II 2013-03-13
K122412 VISIOFOCUS Tecnimed S.R.L. FLL Class II 2013-03-13
K122071 GETINGE 400HC-E / SERIES STEAM STERILIZER Getinge Sourcing, LLC FLE Class II 2013-03-12
K121904 GYNECOLOGY STERILIZATION TRAY Smith & Nephew Inc., Endoscopy Division KCT Class II 2013-03-11
K130034 UNI-PICC Health Line International Corporation LJS Class II 2013-03-08
K121511 MACLIN POWER INTRAVASCULAR ADMINISTRATION SET Maclin Power, Inc. FPA Class II 2013-03-07
K123411 LITTLE ANGELS SWADDLING BLANKET Bionix Development Corp. PDH Class II 2013-03-07
K123344 K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) Kawasumi Laboratories, Inc. FPA Class II 2013-03-07
K121488 JMS SAFE WING CATH (SWC) JMS North America Corporation FOZ Class II 2013-03-05
K123819 MULTIPLE NAME Top Calibre Sdn Bhd LYY Class I 2013-03-05
K130245 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO Baxter Healthcare Corp FMG Class II 2013-03-01
K123749 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE Kossan Latex Industries(M)Sdn Bhd LZA Class I 2013-03-01
K123289 DURABLUE STERILIZATION WRAP Cardinal Health-Medical Products and Services FRG Class II 2013-02-28
K121999 GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE Draeger Medical GmbH FLL Class II 2013-02-28
K123869 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES Dehai (Shandong) Medical Gloves, Co., Ltd. LZA Class I 2013-02-28
K120592 DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS Dana Products, Inc. JOJ Class II 2013-02-27
K123361 ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM Fiab Spa FLL Class II 2013-02-27
K130197 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 Becton, Dickinson and Company ONB Class II 2013-02-27
K122361 T:CONNECT DATA MANAGEMENT SYSTEM Tandem Diabetes Care, Inc. OUG Class I 2013-02-22
K122727 BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE Northstar Healthcare Holdings LZA Class I 2013-02-22
K123175 DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 Conmed Corporation KCT Class II 2013-02-21
K130038 POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE Hl Rubber Industries Sdn Bhd LZA Class I 2013-02-21
K123588 INTRADERMAL ADAPTER West Pharmaceutical Services, Inc. FMF Class II 2013-02-19
K123469 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE Wear Safe (Malaysia) Sdn Bhd - Facility II LZA Class I 2013-02-19
K130049 MONOJECT 12ML SYRINGE Nipro Medical Corporation FMF Class II 2013-02-14
K123116 CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) Worldmed Manufacturing Sdn. Bhd. LZA Class I 2013-02-11
K121280 MYOSURE INTRUMENT TRAY Hologic, Inc. KCT Class II 2013-02-08
K123488 LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE Puyang Linshi Health Co., Ltd. LZA Class I 2013-02-08
K121050 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE Becton, Dickinson & CO NGT Class II 2013-02-07
K123309 GIRAFFE AND PANDA WARMERS Ohmeda Medical FMT Class II 2013-02-05
K122520 DIGITAL THERMOMTER Taidoc Technology Corporation FLL Class II 2013-02-05
K111275 CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE Smiths Medical Asd, Inc. FRN Class II 2013-02-01
K123757 POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR Assurguard Sdn. Bhd. LYY Class I 2013-02-01
K122396 POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Wealth on (Jiangsu) Co., Ltd. LYZ Class I 2013-01-31
K122696 POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) Cardinal Health, Inc. LZA Class I 2013-01-31
K113353 GEMINI STERILZATION WRAP Medline Industries, Inc. FRG Class II 2013-01-31
K123760 MULTIPLE NAME Assurguard Sdn. Bhd. LZA Class I 2013-01-28
K123857 DURABLUE STERILIZATION WRAP Cardinal Health200, LLC FRG Class II 2013-01-23

15,723 clearances in the General Hospital panel. Data: openFDA.