FDA 510(k) clearances — page 1301
clearances on record, most recent first.
Clearances — page 1301
130,001–130,100 of 176,637- K894400 — MICRO-PLATE READER, MDX-1
- K894627 — BT-338N ELECTRONIC CLINICAL THERMOMETER
- K894680 — RS232 FLOW SENSOR AND SOFTWARE PACKAGE
- K895006 — MILENIA(TM) CORTISOL (MKCO1,5)
- K895022 — SYSTEMATE CREATININE TEST (CREA) #65413
- K895086 — GAUZE SPONGE
- K895108 — FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
- K895135 — HI CHEM CALIBRATOR A+
- K895596 — FORTRESS 1000FS ADD-ON POWER UNIT
- K895665 — URIC ACID PAP
- K882270 — MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
- K891301 — PATIENT EXAMINATION GLOVES (LATEX)
- K891458 — SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH
- K892124 — IMPLA-MED IMPLANT SYSTEM
- K893122 — HEATED SERVO HUMIDIFIER, MODEL HDS 2
- K894630 — SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
- K894639 — SKYROCK AND LIGHT SUPERBOND
- K894644 — CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST
- K894658 — KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS
- K894668 — MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
- K894719 — CYPRESS MEDICAL BONE SCREW & PLATES
- K894721 — TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
- K895263 — ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS
- K895348 — MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT
- K895409 — REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
- K895559 — MODIFIED ENDOGUIDE
- K895567 — PRIMIDONE (FPIA) KIT
- K895591 — SILICONE INSTRUMENT SHODS
- K890981 — ELECTRO-TOUCH (ET) GLOVE
- K892644 — BIOLOX CERAMIC BALL
- K892712 — MIP/CT IMAGE PROCESSING WORKSTATION
- K893394 — ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR
- K894632 — MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
- K894642 — SLEEPAP MASK
- K894667 — MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
- K894854 — QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE
- K895138 — CLINISTAT LDH REAGENT TEST
- K895144 — INTERTECH METERED DOSE ELBOW
- K895357 — ANETHESIA BREATHING CIRCUIT
- K895395 — V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
- K895407 — CORTISOL CLASP-BEAD EIA KIT
- K895453 — SPINAL NEEDLE
- K895606 — EXUSORB(TM) GEL DRESSING
- K895718 — LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER
- K895757 — IRRI-EVACUATOR
- K895840 — MILENIA(TM) TOTAL T4 (MKT41,5)
- K895861 — DELTA-TECH(TM) CAST REMOVAL SYSTEM
- K882386 — AGAR 3K NEUROMUSCULAR STIMULATOR
- K893962 — COBE 2991 SUPPLEMENTARY DISPOSABLE SETS
- K894071 — COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE
- K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE
- K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST
- K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST
- K895203 — EN-TRAP SYRINGE
- K895761 — GENERAL ASPERATOR
- K895762 — CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC
- K895897 — MANAN PROSTATIC BIOPSY NEEDLE
- K895986 — PRECISION DENTAL ATTACHMENTS
- K890434 — EMS 300 MUSCLE STIMULATORS
- K890875 — CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
- K893540 — VINYL BAG W/PUMP ADMINISTRATION SET
- K893541 — VINYL BAG W/GRAVITY ADMINISTRATION SET
- K893888 — HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
- K894033 — DISPOSABLE CATHETER PRESSURE TRANSDUCER
- K894494 — LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
- K894504 — WHITESIDE ORTHOLOC M.A. TIBIAL BASE
- K894511 — MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
- K894512 — PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
- K894564 — RELIANCE LIGHT CURE RETAINER ACRYLIC
- K894578 — IQ LDH
- K894633 — CORDIS STEERABLE COATED GUIDEWIRE
- K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
- K894684 — PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT
- K894902 — SOURCERER
- K894934 — HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
- K895047 — CLINISTAT POTASSIUM REAGENT TEST
- K895118 — SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
- K895119 — SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
- K895285 — MENTOR DUCTAL CATHETERS
- K895313 — MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
- K895338 — ANTI-RNP AND ANTI-SM ANTIBODY TEST
- K895380 — SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
- K895496 — BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
- K895643 — MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
- K895752 — DIAMOND BLADE SURGICAL KNIVES
- K895808 — TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
- K895872 — LAN.0800Q/2800Q
- K881777 — LIKON
- K882387 — AGAR 4000 NEUROMUSCULAR STIMULATOR
- K891331 — UNI-STICK PLASTIC LIGATURES
- K891404 — STERILE LATEX SURGEON'S GLOVES
- K893647 — COPOLYESTER FILM DRESSING
- K893753 — DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
- K894261 — TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
- K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN
- K894546 — IMMUNODOT RUBELLA TEST
- K894554 — CLP CK/LD ISOENZYME CONTROL
- K894623 — RESPIRATORY SYNCYTIAL VIRUS
- K894624 — MUMPS VIRUS
- K894626 — EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.