FDA 510(k) clearances — page 831
clearances on record, most recent first.
Clearances — page 831
83,001–83,100 of 176,637- K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
- K001798 — DC TITAN
- K001883 — LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
- K002101 — ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
- K002175 — NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
- K002176 — NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE
- K002323 — ADVANCED UROSCIENCE INJECTION NEEDLE
- K001378 — BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
- K001388 — DATA MASTER PERFUSION MONITORING SYSTEM
- K001873 — HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
- K002211 — COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
- K994161 — SYNTHES BIORESORBABLE SUTURE ANCHOR
- K000050 — TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
- K001349 — CARDIOVISE ECG INTERPRETATIVE SOFTWARE
- K001372 — E-Z LINK CROSS CONNECTOR
- K001374 — PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
- K001385 — HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
- K001419 — SOLAR SHOULDER OFFSET HUMERAL HEAD
- K001527 — FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
- K001536 — INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
- K001616 — MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
- K001728 — HARDY DISK CLARITHROMYCIN, 15MCG
- K001739 — POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
- K001745 — MODIFICATION TO PROVIDENT HIP SYSTEM
- K001748 — MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K001753 — MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K002049 — INVERNESS MEDICAL EARLY PREGNANCY TEST
- K002106 — NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
- K002192 — DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
- K990119 — EPI-STAR SURGICAL LASER SYSTER
- K994398 — INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
- K000887 — DRX HBA1C
- K001092 — GENERIC BLOOD GLUCOSE TEST STRIP
- K001340 — STACKABLE CAGE SYSTEM
- K001350 — PATIENT MATCHED TITANIUM ALLOY TROCHLEA
- K001369 — RESPIEVENTS, VERSION 4.2
- K001445 — SMILIE PC
- K001466 — VOCOM SILICONE SYSTEM
- K001497 — MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
- K001619 — MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
- K001836 — NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
- K001950 — OPTICAL TRACKING SYSTEM (OTS)
- K001959 — POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K001982 — TRI-LOCK HIP STEM
- K002033 — BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
- K990365 — GASTRIC LAVAGE VALVE
- K001314 — MEDSCOPE
- K001323 — NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
- K001375 — ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K001608 — BLAINE SCARCARE PATCH
- K001942 — SL-PLUS AND SLR-PLUS STEMS
- K001957 — MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
- K001989 — COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
- K002115 — A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
- K000580 — ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
- K001032 — RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
- K001391 — BONUS MECHANICAL WHEELCHAIR
- K001407 — SURGITRON IEC II
- K001558 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
- K001777 — MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
- K001890 — SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)
- K001929 — WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
- K001931 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
- K001933 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
- K001934 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
- K002071 — SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
- K002093 — ATRIUM LITE MESH
- K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
- K994158 — MACROSORBOS PROTECTIVE SHEET
- K001919 — WAKO AUTOKIT LP(A)/DADE DEMENSION
- K001920 — WAKO AUTOKIT LP(A)/ RA,500/1000,
- K001921 — WAKO AUTOKIT LP(A)/EXPRESS 550
- K000610 — RESOLUTION CHOLESTEROL MONITOR
- K001050 — CALCIJECT
- K001317 — ARIA
- K001390 — BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
- K001423 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
- K001424 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
- K001426 — KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
- K001446 — LIGHT-CURED ORTHODONTIC BAND CEMENT
- K001530 — THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
- K001541 — MINICAM
- K001750 — MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM
- K001876 — TAKE 1 BITE
- K002046 — MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
- K992414 — PROTON BEAM THERAPY SYSTEM (PBTS)
- K994141 — CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000
- K001087 — PTA BALLOON CATHETER
- K001288 — DR180-II
- K001306 — STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
- K001318 — CPAP SYSTEM, MODEL 102001
- K001357 — MODIFICATION TO OMEGA 21 SYSTEM
- K001376 — TI-MAX PROTRUSIO CAGE
- K001864 — SYNTHES CERVIFIX SYSTEM
- K001885 — VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- K001930 — MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
- K001932 — TORNIER CEMENT RESTRICTOR
- K001966 — REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
- K002126 — ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
- K991279 — MEDI-CULT UNIVERSAL IVF-MEDIUM
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