FDA 510(k) clearances — page 917
clearances on record, most recent first.
Clearances — page 917
91,601–91,700 of 176,637- K963965 — CTS MIDCAB STITCHER
- K971314 — DCAT EMBOLECTOMY CATHETER SYSTEM
- K972873 — IMMUSTRIP HAMA IGG
- K972981 — SHIELD HELICO-G2 ELISA KIT
- K973129 — DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
- K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
- K974778 — ABBOTT GEMSTAR IV INFUSION PUMP
- K974863 — IMIX DIGITAL THORAX SYSTEM
- K980118 — KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER
- K980213 — DI-2000
- K980241 — NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE
- K980247 — GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
- K971612 — OSMO/PCA PILLOW WOUND DRESSING
- K971740 — AMPLAID MK12
- K972241 — ZOLL REVIVER
- K973854 — ORION ANTERIOR CERVICAL PLATE SYSTEM
- K974206 — SYNTHES CRANIAL SPRING CLIP (CSC)
- K974807 — OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
- K974865 — CSR
- K974911 — EXTERNAL FIXATOR
- K980103 — ACUMED SUTURE ANCHOR
- K980201 — DIO-LIGHT LASER SYSTEM
- K980331 — IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
- K980430 — RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
- K980439 — REPLACE CYLINDRICAL IMPLANTS
- K980442 — CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM
- K980582 — MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
- K980677 — NITRILE EXAM GLOVE, POWDER FREE
- K971591 — INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
- K972213 — MS-700
- K972749 — PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
- K973061 — CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)
- K973405 — YEUNG ENDOSCOPIC SPINE SYSTEM
- K973474 — WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
- K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
- K973664 — LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
- K974009 — PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
- K974557 — SMARTTEX
- K974640 — COAXIAL DILATOR SET
- K974642 — COMBICATH CATHETER
- K974653 — SILICONE ELASTOMER SHEETING
- K974670 — ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE
- K974672 — MSI SURGICAL DRAPES
- K974706 — AESCULAP ABC CERVICAL PLATING SYSTEM
- K974720 — HOWMEDICA(R) FULLY THREADED SCREWS
- K974749 — SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS
- K974773 — HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC
- K974817 — DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
- K974870 — LATEX EXAMINATION GLOVE POWDER FREE
- K974903 — GAS MODULE II, MODEL 0998-00-0143
- K974907 — NITRILE PRE-POWDERED EXAMINATION GLOVES
- K980003 — M500-100 SHARPS CONTAINER
- K980071 — SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
- K980163 — WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
- K980167 — POWDERFREE LATEX EXAMINATION GLOVES
- K980194 — POWDERFREE LATEX EXAMINATION GLOVES
- K980215 — LATEX EXAMINATION GLOVES
- K980249 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
- K980275 — POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED)
- K980280 — POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
- K980285 — POWDERFREE BLUE NITRILE EXAMINATION GLOVES
- K980419 — OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE
- K980421 — OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED
- K980511 — NITRILE EXAMINATION GLOVES - POWDER FREE
- K980572 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
- K980618 — LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES
- K971565 — BICOAG COAGULATING FORCEPS
- K973403 — CARDIOSMART ST
- K973640 — TS2000 MEDICAL DEVICE MONITOR
- K973797 — BREATHING CIRCUIT BACTERIAL FILTER
- K974756 — BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
- K974796 — LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
- K970653 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
- K972603 — ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B
- K972777 — TEMPORARY OCCLUSION BALLOON SYSTEM
- K973236 — CREST TOOTHBRUSH WITH MICROSHIELD
- K973238 — ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
- K973800 — 23:1 REDUCTION ANGLE
- K973999 — CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
- K974160 — BRUXTRAK MATERIAL
- K974360 — MULTITEST CD3/CD8/CD45/CD4
- K974628 — FRIALIT-2 PROTECT ABUTMENT
- K974630 — 72 HOUR USE TRACH CARE WITH MICROBAN
- K974671 — ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR
- K974697 — REUSABLE FINGER SENSOR 3444
- K974780 — SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
- K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER
- K980127 — 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT
- K980133 — BAUSCH & LOMB WETTING AND SOAKING SOLUTION
- K980195 — FACEBOW
- K980291 — IMPOWER EXTERNAL VACUUM SYSTEM
- K980318 — POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
- K980532 — QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
- K973377 — SIBELMED AC50D
- K973508 — PYLORI DETECT IGG
- K973679 — AEROETCHER
- K973748 — TEMPO AND TEMP H20
- K973819 — VIDAS D-DIMER (DD) ASSAY
- K974174 — ULTRABUR
Data sourced from openFDA. This site is unofficial and independent of the FDA.