FDA 510(k) clearances — page 500
clearances on record, most recent first.
Clearances — page 500
49,901–50,000 of 175,770- K101460 — LOCI 8 CALIBRATOR, MODEL KC 646
- K101514 — BD DIRECTIGEN EZ RSV
- K101629 — FIL 1520
- K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
- K101680 — WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
- K093801 — IMPELLA CONTROLLER
- K100057 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K100234 — HM-LAMP II
- K100253 — VISUMAX LASER KERATOME
- K100461 — PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
- K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
- K101032 — CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX
- K101060 — SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
- K101144 — MODIFICATION TO:RADIUS SPINAL SYSTEM
- K101415 — THERACLEAR
- K101648 — HI-TORQUE WINN GUIDE WIRE FAMILY
- K100984 — XYLOS VESSEL GUARD
- K091409 — LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
- K093383 — NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
- K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
- K100287 — JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
- K100728 — ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
- K101195 — 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
- K101736 — NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
- K090950 — BONE PLUS BCP
- K092859 — MERITS MODEL N SERIES NEBULIZER COMPRESSORS
- K093189 — ACTIPROTECT UC N95 RESPIRATOR
- K093473 — KMD-MARK1 TISSUE MARKER
- K100302 — MEDLINE PVC URETHRAL CATHETER
- K100414 — PROTOE ENDOSORB SMALL HAMMER TOE PIN
- K100584 — EVIS EXERAII 180 SYSTEM
- K100620 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
- K100979 — NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE
- K101083 — DSS STABILIZATION SYSTEM
- K101403 — ELI 250 ELECTROCARDIOGRAPH
- K101474 — MD VISION SYSTEM
- K101487 — CHEETAH NICOM SYSTEM
- K101667 — ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)
- K101705 — MISTRAL-AIR WARMING SYSTEM
- K092399 — ANTI-MUTATED CITRULLINATED VIMENTIN EIA
- K093877 — RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
- K100059 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
- K100275 — WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
- K100634 — SYNTHES MATRIX SYSTEM
- K100661 — EARPROBE
- K100757 — TILOCK PEDICLE SCREW SYSTEM
- K100816 — PK SUPERPULSE SYSEM GENERATOR MODEL 744000
- K100817 — BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
- K100936 — GYNECARE TVT ABBREVO CONTINENCE SYSTEM
- K101085 — SPINESMITH CYNCH SPINAL SYSTEM
- K101132 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK)
- K101135 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)
- K101190 — LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
- K101293 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
- K101457 — EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
- K101512 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4).
- K101557 — GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
- K101580 — NEV'S INK AUTOCLAVE TAPES
- K101669 — THERMODILUTION CATHETER
- K101685 — IP-SET
- K101711 — CERULEAU ELECTROSURGICAL PROBE
- K090803 — HANSON MEDICAL FACIAL IMPLANTS
- K092815 — S-LIF INTERVERTEBRAL BODY FUSION DEVICE
- K093993 — LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
- K094042 — PEEK PREVAIL CERVICAL INTERBODY DEVICE
- K100373 — TYCHE PEDICLE SCREW SYSTEM
- K101491 — UROSKOP OMNIA
- K101575 — APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
- K101612 — ZEN CORDLESS PROPHY SYSTEM
- K092625 — WAVESTATE NEUROMONITOR
- K092720 — WRIST ARTHRODESIS NAIL SYSTEM
- K092992 — A4-XLR8 FOAM DRESSING
- K093516 — NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
- K093517 — NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE
- K100285 — LITETOUCH MASK
- K100562 — LATITUDE ELBOW PROSTHESIS
- K100940 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965
- K101178 — MODIFICATION TO INTEL HEALTH GUIDE PHS6000
- K101253 — RII INFRARED EAR THERMOMETER, MODEL: TH60N
- K101378 — FRANKENMAN SURGICAL STAPLERS
- K101502 — BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
- K101713 — LIPCOLLECTOR II
- K091807 — MEDPOR FIXATION SYSTEM
- K092985 — BELLECUP
- K100322 — TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
- K100947 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
- K101344 — G+ SYSTEM
- K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
- K091327 — ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
- K091849 — IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
- K092233 — SURGIMESH XD
- K092889 — SYNTEC OSTEO-PLATE AND SCREW FIXATION
- K093104 — MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
- K093196 — BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
- K100001 — MOBIVISION
- K100045 — OCTO
- K100214 — CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
- K100399 — 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
- K100447 — MYOSCIENCE CRYO-TOUCH
- K100694 — COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.