FDA 510(k) clearances — page 909
clearances on record, most recent first.
Clearances — page 909
90,801–90,900 of 175,890- K973548 — MERCURY DENTAL
- K973740 — ROUND WINDOW E-CATH
- K974679 — THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
- K974806 — VYGON NEO-SUMP
- K974819 — SELECTCELLS(TM) MINI
- K980218 — METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
- K980533 — ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
- K980539 — SOLOBOND M
- K980722 — TRIMAX RADIOGRAPHIC CASSETTE
- K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM
- K974611 — MICRO-STRIP FOR AMPHETAMINE METABOLITES
- K974788 — CRE(TM) BALLOON DILATATION CATHETER
- K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
- K974876 — BIONX DISTAL RADIUS SCREW
- K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
- K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
- K980119 — ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
- K980666 — INFINITY AST REAGENT (PROCEDURE NO. 51)
- K980872 — RAPID DRUG SCREEN' 8 PANEL
- K962615 — TUMORLOCALIZER MRI
- K963794 — PUNCTURENEEDLE
- K970093 — TYROSINE 50-HOUR REAGENT KIT
- K973532 — STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
- K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE
- K974202 — PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
- K974464 — ORATEC SPINECATH INTRADISCAL CATHETER
- K974793 — ELMED ESU 120 M/M DIGITAL
- K980001 — JENASCAN
- K980242 — IL TEST HEPARIN
- K980313 — SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
- K980523 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
- K980561 — DERMIUM
- K980565 — LD2000 SERIES
- K980698 — ASTRA TECH IMPLANTS - DENTAL SYSTEM
- K980824 — A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
- K963642 — INCL II ENDOSCOPE
- K972162 — ELECSYS CA 125 II
- K972225 — UFR FIBEROPTIC CABLE
- K973687 — SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
- K974186 — ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
- K974544 — ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
- K974725 — BIOZ.COM SYSTEM
- K974726 — SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
- K974732 — NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
- K974740 — DEPUY TRI-LOCK HIP STEM
- K974746 — M1765A ECG MANAGER
- K974785 — AUTO-DRIVE BONE SCREW
- K974908 — SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
- K980023 — ENDOPATH AND PROXIMATE LINEAR CUTTERS
- K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
- K980377 — FONIX FP35 HEARING AID ANALYZER
- K980454 — LYSONIX ASPIRATION PUMP
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.