FDA 510(k) clearances — page 1038
clearances on record, most recent first.
Clearances — page 1038
103,701–103,800 of 175,890- K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
- K930576 — AT42
- K930577 — AT64 SCR
- K942858 — LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)
- K943541 — 75K STAIGHT DRILL
- K945620 — ALTRA FLUX(TM) 140 HEMODIALYZER
- K945623 — MCA(TM) 130 HEMODIALYZER
- K945624 — MCA(TM) 160 HEMODIALYZER
- K945631 — 155 SCE(TM) HEMODIALYZER
- K951234 — MEDICAL SUPPORT STOCKINGS
- K951253 — AXSYM BARBITURATES II U
- K951287 — AXSYM OPIATES
- K951492 — RIB RESECTOR
- K951872 — STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM
- K942058 — SPACELABS MEDICAL ECG MODULE (MODEL 90492)
- K942351 — DI ISOLATION GOWN
- K943601 — COMFIT (PINK)
- K943696 — ALL POLYETHYLENE CEMENTED ACETABULAR CUP
- K943959 — ECLIPSE 4 ELECTROCARDIOGRAPH
- K944592 — PRECISION OSTEOLOCK FEMORAL COMPONENT
- K945638 — TELPHONIC STETHOSCOPE
- K946084 — VANGUARD
- K946273 — 1700 MONITORING ECG ELECTRODE
- K950119 — OPTA 5(TM) 5F PTA BALLOON CATHETER
- K950250 — MED-SURG SUTURE WASHER
- K950312 — ALPHA SYSTEM
- K950486 — GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE
- K950487 — GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
- K950536 — PICIS CHART+
- K950663 — BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR
- K950713 — AIRGUIDE STYLETTE
- K950907 — PULSE*SPRAY INFUSION SYSTEM
- K951228 — ASH-7000
- K951309 — STONE DISLODGER, BASKET
- K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
- K951590 — ASSURE, SELF-SEALING STERILIZATION POUCH
- K951629 — IMX ESTRADIOL
- K951647 — WELCH ALLYN HI - LUX ILLUMINATOR
- K951661 — PROFEEL
- K951662 — COMFIT/BEADED SURGEON'S GLOVE
- K951667 — COMFIT/GREEN POWDERED EXAMINATION GLOVES
- K951668 — SCIPOTEX/POWDER FREE EXAMINATION GLOVES
- K933077 — EXETER INTRAMEDULLARY BONE PLUG
- K936225 — TS1 TURTLE(TM) SYRINGE
- K941192 — ORTHO ALT MICROWELL TEST SYSTEM
- K944327 — INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
- K944856 — ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
- K945651 — LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3
- K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAY
- K950455 — DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
- K950681 — MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
- K950706 — DRYSLIDE COAGULASE
- K950909 — TRANSIT-2 INFUSION CATHETER
- K950915 — ABBOTT AXSYM II SYSTEM
- K950934 — MPM HYDROGEL DRESSING
- K951167 — EMS I.V. START KIT
- K951182 — RYDER CONTACT LENS CASE MODEL 10670
- K951214 — STERILE EQUIPMENT COVER
- K951286 — AXSYM BENZODIAZEPINES
- K951288 — AXSYM CANNABINOIDS
- K951625 — KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
- K951731 — NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS
- K951860 — HOWMEDICE BONE PLUG
- K951934 — PFC CEMENT RESTRICTOR
- K924306 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
- K925255 — TRAX(TM) CD4 TEST KIT
- K926073 — ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE
- K942346 — IMAGERT
- K943686 — IL TEST BETA-2MICROGLOBULIN
- K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
- K943961 — THE MODEL ACAPPELLA IN THE EAR HEARING AID
- K944280 — TRANSAMERICAN CLASSIC TENS
- K944684 — POLYSCAN DIGITAL SCANNER
- K945022 — APOFIX CERVICAL SPINE FIXATION
- K945131 — IMAGYN INTRAUTERINE INSEMINATION DEVICE
- K945614 — ADD POWER FAMILY , MICRO ADDSTAT
- K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
- K946218 — MARDX ENA EIA TEST SYSTEM
- K946228 — CROSS PIN SCREW SYSTEM
- K950010 — DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
- K950110 — MARDX MITOCHONDRIA EIA TEST SYSTEM
- K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
- K950202 — RINGLOC CONSTRAINED LINER
- K950242 — ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
- K950270 — NMI SOFTWARE
- K950420 — FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
- K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
- K950564 — RICH-MAR US-II ULTRASOUND
- K950586 — AVD INTIMAX THROMBECTOMY CATHETER
- K950751 — TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
- K950752 — ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
- K950753 — CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO
- K951085 — PADGETT AIR DERMATOME, MODEL A
- K951326 — BIOPSY DEVICE ACCESSORY
- K951358 — SIRESKOP SX
- K951396 — KODAK X-OMAT 3000 RA PROCESSOR
- K951397 — KODAK X-OMAT 5000 RA PROCESSOR
- K951427 — AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL
- K951548 — ACE AMYLASE REAGENT
- K951586 — T-UPTAKE EIA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.