FDA 510(k) clearances — page 728
clearances on record, most recent first.
Clearances — page 728
72,701–72,800 of 175,825- K030603 — PROANGLE DISPOSABLE PROPHY ANGLE
- K030620 — PASCO MIC AND MIC/ID PANELS
- K030650 — STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
- K031022 — PROTEC-TOP, STERIDENT, BENTO
- K021154 — GOLDWAY PATIENT MONITOR, MODEL # UT4000F
- K022864 — SK MED M201 MIXER
- K030213 — ONLINE DAT II CANNABINOIDS II
- K030270 — 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
- K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
- K030340 — AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
- K030498 — HL888HA
- K030555 — GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
- K030696 — RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)
- K030772 — RDI EXTENDED RANGE CRP CALIBRATOR SET
- K031003 — STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
- K021237 — COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
- K022417 — CARE STIM
- K022449 — HYSTEREOSCOPY PUMP HM4
- K023096 — CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
- K023621 — BIOFLEX PROFESSIONAL THERAPY SYSTEM
- K023872 — VITALCARE URETHRAL CATHETER RED RUBBER
- K030072 — EVERSTICK PERIO
- K030151 — CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
- K030437 — RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM
- K030594 — I-125 RAPID STRAND, MODEL 7000
- K030804 — BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
- K030833 — DEPUY ACROMED VBR SYSTEM
- K030881 — AVANTA CARPAL FUSION PLATING SYSTEM
- K030909 — AAP ACROPLATE
- K030953 — GE 3.0T GENERAL PURPOSE FLEX COIL
- K023037 — MID STREAM PREGNANCY TEST
- K023311 — LOOP MICROWAVE ABLATION PROBE
- K023412 — THERMO BUDDY, MODELS TB-100, TB-110, TB-120
- K030414 — GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
- K030798 — MIRAGE ACTIVA MASK
- K030801 — BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
- K030823 — ALGO 3I NEWBORN HEARING SCREENER
- K030870 — WBR, MODEL HR
- K030905 — MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
- K030940 — NOMAD ND1000M AUGMENTED VISION SYSTEM
- K030999 — EPTFE VASCULAR PROSTHESIS; SEALPTFE
- K021802 — STEREOTAXIS CATHETER ADVANCER SYSTEM
- K021876 — MAS WITH OR WITHOUT SYRINGE
- K021978 — PETIT SOPHIA
- K022614 — INVIGRA
- K022793 — TETRIS SPINAL IMPLANT
- K023001 — HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
- K030069 — SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
- K030395 — EMPI ACTION PATCH IONTOPHORESIS SYSTEM
- K030457 — REX, VERSION 3.0
- K030656 — ENVAN HEART RATE MONITOR
- K030799 — MICROS 60
- K030806 — BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K030850 — ENHANCE HUMAN SERUM ALBUMIN
- K030982 — SYNGO COLONOGRAPHY SOFTWARE PACKAGE
- K023073 — SEED LINK
- K023614 — STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
- K024339 — COZART EIA OPIATES ORAL FLUID KIT
- K030059 — PORTABLE RO+ MODEL MROS09
- K030061 — PS 3000 DIGATAL PHOTOSPOT SYSTEM
- K030136 — DRIP ALERT
- K030949 — TITAN HIGH RESOLUTION ULTRASOUND SYSTEM
- K023231 — ELFCARE DEVICE, MODELS 314A THROUGH 314G
- K024325 — JI-EE ELECTRIC SCOOTER, ESTHETE ES 1
- K030051 — VERSABOARD, MODEL 7040
- K030092 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K030245 — NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
- K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
- K030548 — SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K030673 — FLEXIBLE TIP THERMOMETER, MODEL 011206
- K030697 — RADIONICS SINGLE USE GROUND PAD (DGP-HP)
- K030707 — WU'S POWERED WHEELCHAIR, MAMBO 3
- K030709 — WU'S POWERED WHEELCHAIR, MAMBO 5
- K030783 — FRONTIER MODEL X5
- K030858 — SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
- K030882 — RABBIT MOBILE STANDING FRAME
- K030890 — SWITCHBLADE
- K022112 — FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
- K022124 — GALEMED PEAK FLOW METER, MODELS 3751/3752
- K023290 — STERRAD 50 & STERRAD 100S STERILIZERS
- K023818 — FIBERFILL AGP
- K024300 — MICROCAP PLUS/NPB-75
- K030062 — ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
- K030110 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
- K030172 — SMALL HIGH SPEED MOTOR DRILL SYSTEM
- K030318 — P2 POLYETHER
- K030562 — TUOHY EPIDURAL NEEDLE
- K030723 — IVS INTRODUCER SET, MODEL 1003
- K030826 — PRECISET DAT AMPHETAMINE
- K023288 — COBRA BIPOLAR CLAMP, MODEL 15902
- K024350 — ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
- K030009 — KSEA POWERSHAVER SYSTEM S2
- K030167 — MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
- K030216 — COLONCARE
- K030323 — MRI-CADDY
- K030686 — OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
- K030736 — VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
- K030818 — HEMOCHRON RESPONSE/SYSTEM
- K030888 — EVA EMPTY SOLUTION CONTAINER
- K030893 — LEVO COMBI
Data sourced from openFDA. This site is unofficial and independent of the FDA.