FDA 510(k) clearances — page 631
clearances on record, most recent first.
Clearances — page 631
63,001–63,100 of 176,637- K060143 — LNCS AND SPO2.COM SENSORS
- K060500 — SPEEDY ORTHODONTIC SCREW
- K060501 — IMPLANTIUM II
- K060819 — COOL.CLICK 2
- K061409 — SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
- K053037 — ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
- K053381 — WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
- K053422 — RAPIDONE-COCAINE-150 TEST
- K060192 — APEX KNEE SYSTEM
- K060237 — CMB ANTIMICROBIAL DRESSING
- K060364 — VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
- K060524 — DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
- K060709 — MULTIGENT GENTAMICIN
- K060817 — OMNILINK. 018 BILIARY STENT SYSTEM
- K060830 — MILAGRO INTERFERENCE SCREW
- K060876 — ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001
- K060946 — CZ-S2000
- K060997 — SNAP II EEG MONITOR
- K061464 — VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
- K061526 — ENSEAL PTC TISSUE SEALING DEVICE
- K052583 — BLUE POWDER FREE NITRILE EXAMINATION GLOVES
- K052759 — DAN MONOPOLAR LAP ACCESSORIES
- K053137 — ENDOTOOL DRUG DOSE CALCULATOR
- K060630 — REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
- K060705 — CARINA HOME
- K060814 — DYNATRON ION IONTOPHORESIS ELECTRODE
- K060875 — ABBOTT AXSYM TROPONIN-I ADV
- K061007 — GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS
- K061080 — IR PRO 250
- K061211 — NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
- K061403 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
- K061437 — SIGMA 5000 SERIES, IMAGIC
- K061475 — ASTROTILT MANUAL WHEELCHAIR
- K060280 — ICHEM 100 URINE CHEMISTRY ANALYZER
- K060311 — EPILONG KIT FOR ANESTHESIOLOGY
- K061051 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
- K061255 — BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
- K061296 — DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
- K061328 — THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
- K052934 — DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
- K060141 — DAI-R
- K060248 — ULTRATINE TRANSBLEPH
- K060249 — ULTRATINE FOREHEAD
- K060668 — SAFE TIP SYRINGE
- K060691 — EASY X-TRAC SYSTEM
- K060716 — VERSA-DIAL HUMERAL HEAD PROSTHESIS
- K061178 — ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
- K061341 — PALMLIGHT 10, MODEL 001-00030
- K061454 — EXACTECH EQUINOXE SHOULDER STEMS
- K061508 — OSOM INFLUENZA A&B TEST
- K052197 — FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
- K052493 — SOCKET GRAFT
- K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER
- K053172 — UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)
- K053444 — KOWA KT-800
- K060402 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
- K060526 — TIPI
- K060686 — MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
- K060766 — PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
- K060853 — ONLINE TDM TOBRAMYCIN
- K060871 — AS101, BLOOD PRESSURE CUFF
- K060896 — MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
- K060914 — TRIDENT ANCHOR
- K061087 — GENESIS OTC MONITOR
- K061088 — SENTRY OTC MONITOR
- K061160 — M-VU CAD STATION
- K061173 — CPIVISION DIGITAL IMAGING SYSTEM
- K061472 — GALILEOS IMPLANT, V 1.0
- K060098 — DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
- K060118 — SSP PEDICLE SCREW SYSTEM
- K060488 — DERMATECH IV HOLDER
- K060537 — EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
- K060858 — LATEX POWDERED EXAMINATION GLOVE
- K060916 — ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.
- K061016 — EBI ESL PEEK-OPTIMA SPINE SYSTEM
- K061047 — HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
- K061144 — DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
- K061154 — KINSA SUTURE ANCHOR
- K061352 — PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
- K061380 — RETAIN RADIOLUCENT SPACER
- K061435 — MEDELA VARIO SUCTION PUMPS
- K052661 — QUIX DIGITAL RADIOGRAPHIC UPGRADE
- K060551 — BRIVANT GUIDEWIRE
- K060627 — TAG-IT CYSTIC FIBROSIS KIT
- K060642 — DUTECK BODY COMPOSITION ANALYZER
- K060820 — CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
- K060910 — POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K061028 — PRECISION THUNIS 800+
- K061061 — 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
- K061097 — COHERENCE DOSIMETRIST, MODEL 2.2
- K061110 — GLUCOMMANDER PLUS
- K061163 — INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
- K061337 — WIEDENT ESTETIC
- K061355 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML
- K052601 — STOCKERT HEATER-COOLER SYSTEM 3T
- K052798 — CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
- K053033 — ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
- K053034 — ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
- K053159 — VECTORVISION SPINE
- K053464 — SERVICE MANAGER SM40SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.