FDA 510(k) clearances — page 776
clearances on record, most recent first.
Clearances — page 776
77,501–77,600 of 176,637- K013168 — IMUBIND PLASMA PAI-1 ELISA,MODEL 822
- K014035 — COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
- K014041 — TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
- K014075 — BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
- K020158 — NON-EUGENOL TEMPORARY CEMENT
- K020518 — MEDELA SYMPHONY BREAST PUMP, MODEL 024
- K020658 — VIATRONIX V3D COLON
- K012414 — PRIME ECG SYSTEM
- K012957 — TOWEL DRAPE, MODELS 4409, 4410
- K013473 — XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
- K014111 — REBILDA SC
- K020156 — DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
- K020359 — ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES
- K020369 — ELECSYS ANTI-TG CALCHECK
- K020511 — MICROSCAN SYNERGIES PLUS
- K010761 — SPL-50 SPIROLYSER
- K012189 — ANGELTOUCH VENTED IV ADMINISTRATION SET
- K013433 — TROJAN PASSION BERRY GEL
- K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
- K013774 — CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA
- K013821 — SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K014060 — MICROAIRE 1000E SYSTEM
- K014081 — AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES
- K014204 — ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
- K020060 — ASTOFLO
- K020243 — LASERPRO 16
- K001638 — O-RING PROSTHETIC ATTACHMENT
- K011269 — LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR
- K012294 — WRISTORE FIXATOR
- K012732 — INTEGRAPH FLASH, MODEL CI 110
- K013353 — NEUROSPECTQUAD GAMMA CAMERA
- K013680 — CARBODISSECTING ENDOSCOPE
- K013876 — INFRARED EAR THERMOMETER, MODEL DX-707
- K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
- K014022 — MRI LINE MARKER
- K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
- K014087 — LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE
- K014170 — STAURENGHI WIDE FIELD SCANNING LASER LENS
- K020068 — SONOREAL 3D SYSTEM
- K020137 — AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
- K020157 — TEMPORARY CROWN AND BRIDGE MATERIAL
- K020223 — INVIGRA
- K020428 — ENDOPATH DILATING TIP TROCAR, MODEL #512XD
- K020497 — TRIDENT ELEVATED RIM LINER
- K020572 — ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
- K011030 — AESCULAP -MIETHKE SHUNT SYSTEM
- K012535 — DRG DISPOSABLE VAGINAL SPECULUM
- K013054 — KONICA DIRECT DIGITIZER REGIUS MODEL 350
- K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
- K013987 — REPROCESSED DISPOSABLE TROCARS
- K014276 — MODIFICATION TO EBI XFIX DFS SYSTEM
- K014300 — SAFETOUCH
- K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
- K020340 — MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
- K020521 — MODIFICATION TO VIGIL LIPID CONTROL
- K012357 — CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K012633 — RESPIRONICS HEATED HUMIDIFIER
- K012640 — ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
- K012975 — SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
- K013148 — BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
- K013819 — URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
- K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE
- K013952 — INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
- K013954 — LORENZ SELF DRILLING SCREWS
- K013963 — MODEL 9210 DELIVERY CATHETER, MODEL 9210
- K014047 — APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
- K014110 — SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT
- K014112 — SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E
- K014142 — UNITE BONDING ADHESIVE
- K014203 — ABX MICROS 60 HEMATOLOGY ANALYZER
- K014295 — STAT PROFILE PHOX ANALYZER
- K020023 — DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
- K020115 — PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
- K020117 — GC FUJI LINING LC PASTE PAK
- K020131 — VENUS UNIVERSAL LIGHT CURING COMPOSITE
- K020193 — OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
- K020282 — JAS AMYLASE LIQUID REAGENT
- K020483 — ADVANTAGE WORKSTATION 4.1
- K020504 — INFRARED EAR THERMOMETER, MODELS TH88 SERIES
- K013216 — DIODENT DENTAL LASER SYSTEM
- K013651 — INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
- K013941 — PULSION FS LASER KERATOME
- K013946 — FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
- K013990 — LIFESTITCH SUTURING DEVICE
- K014059 — PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
- K014115 — 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
- K020288 — PADPRO, MODEL 2603
- K020291 — EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
- K020338 — STEALTHSTATION WITH FLUOROMERGE SOFTWARE
- K020463 — DEPILASE YAG LASE PLUS LASER SYSTEM
- K010797 — RUSCH MILLER-ABBOTT TUBE
- K010798 — RUSCH CANTOR TUBE
- K013107 — BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
- K013361 — WIN-2 TANGO ELITE NP
- K013940 — LASER SYSTEM YELLOWSTAR
- K013953 — AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
- K013973 — ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC
- K013996 — LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
- K020044 — VINYL EXAMINATION GLOVES STERILE POWEDERED
- K020132 — CHASE CARDIOVASCULAR PATCH KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.