FDA 510(k) clearances — page 747
clearances on record, most recent first.
Clearances — page 747
74,601–74,700 of 175,825- K021142 — ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
- K021389 — BIOLOGICAL SOUND MONITOR (BSM) SENSOR
- K021454 — UNITY NETWORK ID
- K021495 — QIVA
- K022181 — NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
- K022298 — I-STETHOS LINK
- K022380 — LIVESIRE ELECTROPHYSIOLOGY CATHETER
- K022455 — SPIFE LD-12 KIT, MODEL 3338
- K023010 — SNIFF POSITION PILLOWS/POPITZ PILLOWS
- K012138 — MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
- K013837 — BIO-RAD PLATELIA TOXO IGM TMB
- K013839 — BIO-RAD PLATELIA TOXO IGG TMB
- K022140 — WHISPER WEAR BREAST PUMP
- K022154 — LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
- K022406 — EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
- K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
- K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
- K022519 — LDL CHOLESTEROL (AUTOMATED)
- K022533 — FASTPACK TESTOSTERONE CALIBRATOR
- K022922 — HARMONY INR MONITORING SYSTEM
- K023062 — GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
- K013875 — MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
- K020542 — DAYTRIPPER DIALYSATE WARMER
- K021266 — ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
- K021793 — EBV EA-D IGG ELISA KIT, MODEL EBG-100
- K021814 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
- K022103 — PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
- K022115 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
- K022297 — GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
- K022424 — REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162
- K022552 — ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- K022560 — M2 SINGLE USE MICROKERTOME
- K022851 — PH AND AMINES EXTERNAL CONTROL SET
- K022883 — HRK-63 KNEE ARRAY COIL
- K022901 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
- K020457 — AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
- K020903 — DOCXS B SERIES ELECTRODES
- K021131 — CHLORAPREP
- K022084 — ATLAS MONITOR, MODELS 200,210,220
- K022458 — AUTO*THERM 395, MODEL ME 395
- K022522 — PULPDENT PUTTY DAM
- K022792 — CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED)
- K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
- K023024 — TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
- K023045 — MICRORUPTER V
- K023113 — REPLACE TIUNITE ENDOSSEOUS IMPLANT
- K020786 — INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
- K020879 — IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001
- K021997 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K022100 — NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
- K022659 — ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
- K022775 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
- K022889 — SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
- K022983 — BARDPORT X-PORT ISP PORT
- K022990 — REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
- K022992 — REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
- K023015 — CARDIS
- K020280 — PULMOLAB EX671 EXERCISE TESTING SYSTEM
- K020712 — ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
- K021152 — ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
- K021248 — ICASE
- K022076 — FIRST CHOICE & FIRST CHOICE PLUS
- K022079 — SHORT AND LONG SOFT TISSUE ATTACHMENT
- K022187 — PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
- K022344 — TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
- K022374 — CADENCE SPINAL FIXATION SYSTEM
- K022413 — LUNEAU 3 MIRROR LENS
- K022755 — LIFEGUARD
- K022819 — NELLCOR N-200 PULSE OXIMETER, MODEL N-200
- K022898 — PTS PANELS LIPID PANEL TEST STRIPS
- K022968 — ADVIA TESTPOINT CSF CONTROL
- K013974 — RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A
- K020571 — STOCKERT CENTRIFUGAL PUMP CONSOLE
- K020808 — FERTILITE OV
- K020848 — NAFD 100
- K020851 — TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D
- K021740 — TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
- K021864 — PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
- K022068 — TUBING, DIALYSATE (AND CONNECTOR)
- K022138 — SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
- K022139 — HIP TOOL IMPLANT
- K022220 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
- K022271 — PLUS PIVOT LINK UNIVERSAL SYSTEM
- K022287 — 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
- K022549 — RESTORATION MODULAR SYSTEM
- K022632 — SIGN IM NAIL
- K022676 — ORTHOGUARD AB ANTIMICROBIAL SLEEVE
- K022725 — CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
- K022771 — TWIN FIX
- K022879 — MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
- K021648 — QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
- K021746 — SQA V, SPERM QUALITY ANALYZER
- K022061 — CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER
- K022093 — CHASE CARDIOVASCULAR PATCH KIT
- K022099 — SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
- K022411 — PRECISEPLAN 2.0
- K022869 — SOAKER CATHETER
- K022912 — POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
- K021646 — BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
- K021649 — BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
Data sourced from openFDA. This site is unofficial and independent of the FDA.