FDA 510(k) clearances — page 407
clearances on record, most recent first.
Clearances — page 407
40,601–40,700 of 175,770- K122988 — KLOCKNER DENTAL IMPLANT ABUTMENTS
- K124055 — T1040 AKA AURAWAVE
- K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
- K130079 — MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
- K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
- K130658 — ELIXBO PM545
- K130731 — STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
- K131130 — NAVIGATION PIN
- K131203 — IHEALTH CLOUD
- K131332 — CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
- K131811 — UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
- K123332 — NAOMI-CT
- K130088 — PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
- K130224 — ICT
- K130399 — CERTUS 140 CERTUSURGGT SURGICAL TOOL
- K131046 — VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
- K131137 — 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
- K131179 — CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
- K131327 — BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
- K131467 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K131688 — NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
- K131776 — ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
- K131805 — INPULSE LASER
- K131905 — SOLID GEL PAD
- K113126 — ACRYLIC HERBST APPLIANCE
- K123660 — 25-OH VITAMIN D ELISA
- K123753 — IMDX VANR FOR ABBOTT M2000
- K123787 — GREENCROSS SURGICAL MASK
- K130083 — DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
- K130766 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
- K130906 — ENDOFLIP CATHETER
- K130987 — VALUTRODE NEUROSTIMLATION ELECTRODES
- K131077 — LIFE SPINE PLATEAU SPACER SYSTEM
- K131544 — COBAS C BILIRUBIN TOTAL GEN.3
- K131853 — MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
- K122402 — LPP (LOW PROFILE PORT)
- K130536 — EXPORT ADVANCE ASPIRATION CATHETER
- K131120 — AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
- K131233 — HERMES MEDICAL IMAGING SUITE V5.3
- K131358 — BD PEN NEEDLE
- K131428 — RADVISION
- K131434 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
- K131504 — UNIVERSAL OPAQUE
- DEN110019 — NEBA SYSTEM
- K123364 — 25OH VITAMIN D TOTAL ELISA TEST
- K130051 — 611 ANKLE FUSION NAIL
- K130186 — DENTEK EASY BRUSH WITH FLUORIDE
- K130253 — TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
- K130360 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
- K130585 — PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
- K130657 — LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
- K130953 — NEOTIS; NEOTIS 50
- K131040 — EXTAVIPRO STERICAN 30G
- K131185 — ANA SCREEN ELISA (IGG)
- K131382 — EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
- K131763 — TRUSCOPE SERIES PATIENT MONITOR
- DEN110004 — CABOCHON SYSTEM
- DEN110006 — VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
- K123366 — SURGITRON 4.0 DUAL RF S5-IEC
- K123599 — INGENUITY DIGITAL PET/CT
- K130315 — IPULSE HAIR REMOVAL SYSTEM
- K130420 — SOLEA
- K130806 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
- K131036 — YAMAHACHI DENTURE BASE RESINS
- K131087 — SHARPSTANK REUSABLE SHARPS CONTAINER
- K131227 — PADSCAN HD SERIES BLADDER SCANNER
- K131417 — FACET FIXX
- K131424 — MIPLATFORM MEDICAL IMAGING SUITE
- K131514 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
- K131547 — LANX FUSION SYSTEM
- K131637 — ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
- K131804 — REMEL XPECT FLU A&B
- K121310 — MESOTHELIUM DENTAL MEMBRANE
- K123075 — BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
- K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
- K123881 — HEARTSINE SAMARITAN PAD 350P
- K130225 — QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
- K130339 — CLINICAL ALERT NOTIFICATION
- K130424 — STIMEL-03
- K130460 — NXSTAGE DOSING CALCULATOR
- K131248 — ETCH GEL
- K131278 — MONTERIS MEDICAL NEUROBLATE SYSTEM
- K131282 — NEXUS HEMORRHOID LIGATOR
- K131520 — NEXUS ANTERIOR CERVICAL PLATE SYSTEM
- K124045 — FUSEFORCE IMPLANT SYSTEM
- K124062 — QDC-PRO, AND NOX-RIP
- K130391 — EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
- K131007 — AIGIS RX N MEDIUM; AIGIS RX N LARGE
- K131269 — DLP CORONARY OSTIAL PERFUSION CANNULAE
- K131331 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
- K131338 — DERMA HOOD
- K131496 — BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
- K131738 — IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
- K130324 — STATSEAL DISC
- K130879 — NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS
- K131072 — ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
- K130676 — AMBIO REMOTE HEALTH MONITORING SYSTEM
- K131463 — WRIST AUTOMATIC BLOOD PRESSURE MONITOR
- K130183 — SFI BAR ABUTMENTS
- K121178 — TRANSCORP ACIF SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.