FDA 510(k) clearances — page 464
clearances on record, most recent first.
Clearances — page 464
46,301–46,400 of 175,770- K110914 — TRIPLE LUMEN PFM PICC
- K111370 — ODALYS PEDICLE SCREW SYSTEM
- K111833 — VIRTUE
- K111857 — SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
- K111868 — STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
- K111876 — Z BOND, PRELUDE ONE
- K111936 — ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
- K111973 — VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
- K112159 — CMS-1000FM CENTRAL MONITORING SYSTEM
- K112187 — FM-1000 PLUS FETAL MONITOR
- K101185 — NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
- K101356 — Spacer-G and Spacer-K
- K110493 — TANDEMHEART PUMP
- K111223 — AMSCO CHIMERON SMALL STEAM STERILIZER
- K111279 — NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
- K111451 — MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
- K111576 — NT 2000 LESIONING GENERATOR
- K111710 — FULL AUTO TONOMETER MODEL TX-20
- K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)
- K112253 — CERALAS 147NM DIODE LASER SYSTEM
- K112257 — BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
- K103290 — EDLEN IMAGING - GEMINI DUSB
- K111174 — NXSTAGE PUREFLOW SL
- K111912 — MOBILETT MIRA
- K112236 — WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
- K112356 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
- K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
- K100806 — DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
- K102359 — PICASSO/ PICASSO LITE/ PICASSO PERIO
- K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
- K111278 — Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
- K111355 — ECHOBRIGHT
- K111490 — MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
- K111559 — SURGICAL MASKS
- K111629 — TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
- K111711 — JOURNEY II BCS KNEE SYSTEM
- K111720 — AVIAFIT
- K111728 — EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K111782 — BEAUTISEALANT
- K111836 — PERMASHADE VENEER CEMENT
- K112067 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K112451 — S8 DIAGNOSTIC ULTRASOUND SYSTEM
- K112596 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K101898 — R4 ACERT ULTRASOUND REPORTING SYSTEM
- K102816 — GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
- K103089 — SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS
- K103515 — EQUAL DOSE
- K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
- K110033 — FEEL-DRCS
- K110370 — Q-CLEAR
- K110766 — KOLPLUX SYSTEM
- K111003 — BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
- K111457 — CD HORIZON SPINAL SYSTEM
- K111510 — CD HORIZON SPINAL SYSTEM
- K111694 — ASTRA
- K111731 — MOLECULAR BREAST IMAGING SOFTWARE
- K111763 — PATHASSIST LIGHT FIBER
- K111767 — NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
- K111966 — PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
- K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
- K112075 — VITEK 2 STRPTOCOCCUS AMPICILLIN
- K112176 — SILICONE SPHERES
- K112360 — QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
- K112366 — 4CH FLEX SPEEDER
- K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
- K112385 — TRAGET DETACHABLE COIL
- K103426 — LITE PELVIC FLOOR REPAIR KITS
- K103648 — COLLAGEN POWDER
- K103810 — KJ SUBMERGED SYSTEM
- K110309 — FOB ONE STEP RAPID TEST
- K111322 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
- K111360 — SHEAUMANN PL-980
- K111612 — DIGITAL RETINAL CAMERA
- K111743 — THE INSYNC CERAMIC SYSTEM
- K111814 — PADLOCK
- K111996 — ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
- K112113 — ELECSYS MYOGLOBIN CALCHECK 5
- K112196 — OCTOTMPORT
- K112198 — EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
- K112465 — VITAL SIGNS MONITOR
- K101769 — EPISIL
- K102483 — SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
- K103461 — COLGATE DESENSITIZING DENTAL CREAM
- K110659 — MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
- K110891 — THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER
- K110945 — POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
- K111115 — CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
- K111270 — REUSABLE STIMULATING ELECTRODES
- K111359 — SHEAUMANN PL-1064
- K111660 — XELIS CARDIAC
- K111775 — JBAIDS INFLUENZA A&B DETECTION KIT
- K111778 — JBAIDS INFLUENZA A SUBTYPING KIT
- K112031 — ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
- K112047 — AMCOM COMMTECH MESSENGER
- K110713 — WATERPAP VALVE
- K111177 — JUELL HARD CURE
- K111178 — JUELL SOFT CURE
- K111390 — SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
- K111438 — REKA E100
- K111484 — DISCOVERY
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