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General Hospital

15,616 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
NIPRO SUREFUSER AMBULATORY INFUSION PUMP (K051828)Nipro Medical Corporation2005-12-15
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K052635)Teh Loong Corp.2005-12-13
WINNER SELF SEAL STERILIZATION POUCH (K051242)Winner Medical (Usa), Inc.2005-12-13
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES (K053120)Excelsior Medical Corp.2005-12-09
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP (K052221)Sorenson Medical, Inc.2005-12-08
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS (K052887)Terumo Europe N.V.2005-12-08
ROBIN HOOD VEST (K051300)Kamber Corporation2005-12-08
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 (K053129)Nexus Medical, LLC2005-12-08
MPS ACACIA MEDFLO ELASTOMERIC PUMP (K052451)Mps Acacia2005-12-08
VERIFY FLASH INTEGRATOR (K051101)Albert Browne , Ltd.2005-12-06
POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR (K050526)Spi Gloves Sdn. Bhd.2005-12-06
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES (K052728)M/S. Kanam Latex Industries Pvt. , Ltd.2005-12-05
DUOPROSS NEEDLE (K052445)Duopross Meditech Corporation2005-12-05
MEDI BUTLER (K051324)Medi USA, LP2005-12-05
SERIM PERACETIC ACID CHEMICAL INDICATOR (K052388)Serim Research Corp.2005-12-01
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 (K052892)Barriermed Glove Co.2005-11-30
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 (K052431)Medtronic Minimed2005-11-29
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX (K052387)Arthrex, Inc.2005-11-29
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 (K052432)Medtronic Minimed2005-11-29
ESTEEM STRETCHY VINYL GLOVE WITH COATING (K052568)Cardinalhealth2005-11-28
ARTSANA PISTON AND INSULIN SYRINGES (K052667)Artsana S.P.A2005-11-25
OMNIPICC PI (K051102)Rita Medical Systems, Inc.2005-11-23
POWERPICC (K051672)Bard Access Systems, Inc.2005-11-23
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS (K050800)Caesarea Medical Electronics , Ltd.2005-11-23
TERUMO MICRO TAPERED PEN NEEDLE (K052561)Kofu Factory of Terumo Corp.2005-11-23
CRONO FIVE AND CRONO PCA 50 (K052218)Cane S.R.L.2005-11-23
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR (K052612)Shanghai Antares Industries, Inc.2005-11-22
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES (K052502)Yty Industry (Manjung) Sdn Bhd2005-11-18
EZ-IO (K052408)Vidacare Corporation2005-11-17
CADD-MS 3 AMBULATORY INFUSION PUMP (K051568)Smiths Medical MD, Inc.2005-11-17
CONTRAST MEDIA TRANSFER SETS (K052252)B.Braun Medical, Inc.2005-11-16
TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K052636)Teh Loong Corp.2005-11-10
NIPRO HYPODERMIC NEEDLE (K052474)Nipro Medical Corp.2005-11-10
PROCEDUR-10 (K052075)Avanca Medical Devices, Inc.2005-11-09
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) (K051082)Medtrade Products , Ltd.2005-11-08
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE (K052877)Syntex Healthcare Products Co., Ltd.2005-11-08
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE (K052709)Pt.Shamrock Manufacturing Corp.2005-11-08
EZ-MIO MANUAL DRIVER (K052195)Vidacare Corporation2005-11-02
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS (K052722)Hospira, Inc.2005-11-02
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E (K052890)Siam Sempermed Corp., Ltd.2005-10-31
INFRARED THERMOMETER, FDIR-V1 (K052849)Famidoc Technology Co., Ltd.2005-10-26
IN6 SAFETY SYRINGE, MODEL 3ML (K051800)In6 Incuvestor, Inc.2005-10-21
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM (K051992)Vidacare Corporation2005-10-20
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE (K051991)C.R. Bard, Inc.2005-10-20
ALARIS SYSTEM PC UNIT, MODEL 8001 (K051641)Cardinal Health, Alaris Products2005-10-20
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR (K051056)Albert Browne , Ltd.2005-10-20
EXEL SECURE TOUCH II SAFETY SYRINGE (K052103)Exelint Intl. Co.2005-10-19
VITAGEL SURGICAL HEMOSTAT SPRAY SET (K052173)Orthovita, Inc.2005-10-19
STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES (K052085)Asia-Med GmbH and CO KG2005-10-14
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE (K052171)Zimmer, Inc.2005-10-13
SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET (K052658)Renascence Medical, Inc.2005-10-12
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE (K052634)Teh Loong Corp.2005-10-11
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (K051869)Natus Medical, Inc.2005-10-07
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE (K051987)Pt. Mandiri Inti Buana2005-10-06
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES (K051783)Artsana S.P.A2005-10-04
SUREFLOW SAFETY INFUSION DEVICE (K051943)Intrasafe Medical, LLC2005-10-04
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 (K052516)Steritec Products, Inc.2005-10-03
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE (K052551)Devon Safety Products, Inc.2005-09-30
POWDERED LATEX PATIENT EXAMINATION GLOVES (K051913)Shinemound Enterprise, Inc.2005-09-30
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE (K052273)Pt Mahakarya Inti Buana2005-09-30
B-CARE POWDER FREE LATEX EXAMINATION GLOVES (K051404)B-Care Industries Co., Ltd.2005-09-27
EZ-JECT (K051667)Indolor, Ltd.2005-09-27
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR (K051865)Terumo Medical Corp.2005-09-27
NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702 (K051835)Norm Pacific Automation Corp.2005-09-23
VANISHPOINT I.V. CATHETER (K051355)Retractable Technologies, Inc.2005-09-23
SAF-T-SYRINGE/SAF-T-NEEDLE (K051762)Safety Medical International, Incorporated2005-09-23
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES (K051873)GE Healthcare2005-09-20
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K052382)Pt.Shamrock Manufacturing Corp.2005-09-15
PRE-POWDERED STERILE EXAM GLOVES (K052214)Kanam Latex Industries Pvt. , Ltd.2005-09-13
CRONO GO. (K052219)Cane S.R.L.2005-09-13
BD PEN NEEDLE (K051899)Becton, Dickinson & CO2005-09-13
CRONO SUPER PID (K052217)Cane S.R.L.2005-09-13
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K050760)Roche Diagnostics Corp.2005-09-13
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES (K051269)Radiant Innovation, Inc.2005-09-09
I-PORT (K052389)Patton Medical Devices2005-09-09
TRU-SWAB STOCOCK (K052330)Medegen Medical Manufacturing Services2005-09-09
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) (K052117)I-Flow Corp.2005-09-09
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 (K051251)Shenzhen Dongdixin Technology Co., Ltd.2005-09-07
POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW) (K051924)Shijiazhuang Manful Light Industrial Products Co.,2005-09-02
YI XIN STERILE SYRINGE FOR SINGLE USE (K050999)Jiangxi Sanxin (Eversincere) Medical Devices Group2005-09-02
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE (K051422)Medisim, Ltd.2005-09-01
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS (K051264)Unomedical A/S2005-09-01
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K051669)Migada Plant2005-09-01
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS (K051157)Micromedics, Inc.2005-09-01
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING (K052016)Sgmp Co., Ltd.2005-09-01
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE (K051574)Nipro Medical Corp.2005-08-26
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH (K050889)Crs Medical Diagnostics, Inc.2005-08-26
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 (K052052)Hospira, Inc.2005-08-24
VITALCARE I.V. ADMINISTRATION SET (K050906)Vitalcare Group, Inc.2005-08-23
STERRAD STERILIZER CYCLESURE TEST PACK (K051643)Advanced Sterilization Products2005-08-19
VYGON NUTRILINE CATHETERS (K051690)Vygon Corp.2005-08-19
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (K051985)Biovalve Technologies, Inc.2005-08-17
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER (K052128)3M Company2005-08-16
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) (K050971)Biovalve Technologies, Inc.2005-08-16
TERUMO SYRINGE WITH/WITHOUT NEEDLE (K052034)Terumo Medical Corp.2005-08-16
POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED) (K051923)Shijiazhuang Wonder Plastic Co., Ltd.2005-08-16
DRUG ACCESS SPIKE (K051930)Medegen Medical Manufacturing Services2005-08-16
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370)Baxter Healthcare Corp2005-08-12
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) (K051777)Hartalega Sdn Bhd2005-08-12
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (K051660)Coltene/Whaledent, Inc.2005-08-04
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