FDA 510(k) clearances — page 939
clearances on record, most recent first.
Clearances — page 939
93,801–93,900 of 176,637- K964908 — VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
- K970581 — CLINIJEL
- K970835 — FACE MASK, SURGICAL MASK, NON-STERILE
- K971132 — ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
- K971176 — VIEW ARCHIVING STATION
- K971717 — FLY THROUGH
- K972139 — ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
- K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
- K972103 — PHILIPS EASYVISION
- K972113 — 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
- K972556 — QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
- K972663 — SMART SET
- K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
- K973115 — ARRIPRO 35 ST/TV
- K960756 — LIFETECH CASSETTE
- K962167 — BRONCHIAL BLOCKER
- K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK
- K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
- K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS
- K970296 — ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
- K970347 — MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
- K971102 — AMBIDERM
- K971200 — W.A.
- K971219 — CRYO CHECK INR VALIDATION SET
- K971998 — ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
- K972035 — SPOROX TEST STRIPS
- K972055 — MSI MAGNA-STYM
- K972091 — AMS FOREIGN BODY EXTRATOR
- K972115 — VOLKER HOSPITAL BED, MODEL K960
- K972122 — DREAM CATCHER
- K972279 — SHARPS SHUTTLE
- K972355 — 3M AURORA SYSTEM
- K972403 — BTI CORTICAL BONE SCREWS
- K972411 — LINK CEMENT PLUG
- K972414 — FRESHCELLS
- K972421 — EASY BOND
- K972583 — URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
- K972586 — AIA-PACK TSH 3RD-GEN ASSAY
- K972606 — PREGNACOL PREGNANCY TEST
- K972742 — QUICKVUE ONE-STEP HCG-URINE
- K972748 — CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE
- K972976 — CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
- K970769 — COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
- K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH
- K972059 — QUIKPAC II ONE STEP COCAINE TEST
- K972175 — INFUSASLEEVE IIA (IS-2A)
- K972359 — REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
- K972409 — AG CHEMISTRY ANALYZER SYSTEM
- K972466 — SODIUM CHLORIDE INHALATION SOLUTION, USP
- K972467 — STERILE WATER FOR INHALATION, USP
- K972812 — RAICHEM PREALBUMIN SPIA
- K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR
- K972868 — TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
- K972941 — AURECAST 74
- K972942 — AURECAST 83
- K964779 — MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE
- K965237 — NURSES BOUFFANT CAP
- K965244 — Z TECH TRANSCUTANEOUS NEURAL STIMULATION
- K971166 — OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
- K971316 — POLY (VINYL) EXAM GLOVE, POWDERED
- K972002 — CYNOSURE DERMATOLOGY LASER COOLING TIP
- K972099 — SHARPLAN EPITOUCH RUBY LASER SYSTEM
- K972299 — BERGEN MODEL 500 ELECTROSURGERY GENERATOR
- K972469 — SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE
- K972497 — KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
- K972628 — THERMOGARD & THERMOGARD PLUS ABC
- K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
- K970165 — EVITA 2 DURA
- K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
- K970836 — TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
- K970927 — BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
- K971736 — SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
- K971763 — BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
- K971986 — VALLEY FORGE BIPOLAR LOOP
- K972013 — NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
- K972117 — MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW
- K972134 — BAG DECANTER
- K972135 — MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
- K972183 — DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
- K972231 — OSOM MONO TEST 143
- K972240 — IMTEC BIOBARRIER MEMBRANE
- K972319 — AURECAST GF
- K972356 — INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
- K972444 — 3I INNOVATIVE IMPLANTS AND COVER SCREWS
- K972503 — CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
- K972508 — SURGICAL BURS AND SURGICAL DRILL BITS
- K972594 — METALPRIMER II
- K972810 — OPT80 THE TRANSPORTABLE (OPT80)
- K972939 — AURECAST BIO 59PF
- K972940 — AURECAST BIO 69PF
- K973063 — FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
- K970135 — NITRILE GLOVES
- K970646 — SAFARI
- K970686 — ACCUTEMP-PROBE
- K970990 — GYREX PRIMA 1TG 1.0T MRI SYSTEM
- K971044 — DASH, SULLIVAN, VITAL GARD
- K971146 — LAPARETTE
- K971397 — VIEWCATH 3-D CATHETER PULLBACK
- K971938 — REPICCI II UNICONDYLAR KNEE
- K971946 — NPB-190 PULSE OXIMETER (NPB-190)
Data sourced from openFDA. This site is unofficial and independent of the FDA.