FDA 510(k) clearances — page 886
clearances on record, most recent first.
Clearances — page 886
88,501–88,600 of 175,890- K983028 — FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K983085 — HEMOCOR HPH 700 HEMOCONCENTRATOR
- K983135 — BLOWER/MISTER
- K983357 — MUCOPREN SOFT RELINING SYSTEM
- K983361 — PANAVIA F
- K983582 — CARDIOBEEPER CB250
- K983786 — STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION
- K974241 — SCIMED INFORMER PRESSURE WIRE SYSTEM
- K980711 — HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
- K981072 — ESPRIT VENTILATOR
- K981885 — SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
- K981911 — PROFA
- K982831 — AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
- K982906 — LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
- K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
- K983323 — DIGOXIN IMMUNOASSAY
- K983450 — STARRYSHINE GAUZE SPONGE
- K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
- K983517 — SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
- K983578 — ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
- K983602 — CV PERI-GUARD AND VASCU-GUARD
- K983706 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
- K983771 — STRATEGY CORONARY WIRE GUIDE
- K973322 — DIAPACT CRRT
- K982843 — CMS-2000
- K982854 — MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
- K982876 — HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
- K982902 — PERIPHERAL NERVE STIMULATION
- K982975 — DIGITAL ECG HOLTER RECORDER, MODEL DR512
- K983033 — ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
- K983112 — RESPIRATORY HUMIDIFIER, MODEL # MR850
- K983554 — ALLDRESS, ABSORBENT FILM DRESSING
- K983603 — REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
- K983736 — ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
- K980800 — LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
- K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
- K982043 — BRENEB
- K982167 — CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
- K982840 — BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING
- K983266 — FIBREKOR POST SYSTEM
- K983478 — ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
- K973585 — PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
- K980895 — ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
- K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
- K981462 — QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300
- K981526 — ACE ALVEOLAR DISTRACTOR
- K982110 — POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
- K982410 — SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
- K982435 — IRRIGATION SYRINGE KIT
- K982575 — MESH, SURGICAL, POLYMERIC
- K982813 — NATURALYTE, MODEL # 08-4004-1
- K982815 — ALPHATRAC, MODEL A200
- K982825 — BRENNEN MEDICAL BETA GLUCAN GEL
- K982826 — MEGA 2000
- K982828 — FORTE, MODELS CPS 400 STIM, CPS 200 STIM
- K982829 — FORTE, MODEL CPS ULTRASOUND
- K982830 — FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
- K982837 — KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
- K982933 — VINYL EXAMINATION GLOVES, POWDER FREE
- K983025 — XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
- K983092 — TRITON HUDSON CHUCK ATTACHMENT
- K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
- K983218 — N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
- K983280 — VANCOMYCIN EIA ASSAY
- K983283 — SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM
- K983367 — QLICKSMART
- K983405 — ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
- K983407 — ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
- K983520 — BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD
- K983538 — MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
- K983581 — OCU-GUARD AND OCU-GUARD SUPPLE
- K983585 — LOW PH PHENOLIC 256
- K983632 — SIEMENS SC 8000 BEDSIDE MONITOR
- K983677 — QUICKIE G SERIES, MODEL G-424
- K983684 — DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
- K980129 — INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS)
- K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
- K981064 — POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
- K982166 — CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
- K982720 — H-RAY
- K982821 — MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
- K983151 — IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
- K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
- K983287 — MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
- K983494 — VINYL EXAM GLOVES, POWDER FREE
- K983608 — EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK
- K983612 — POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
- K971616 — BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
- K973765 — BIO-2000
- K981556 — CANON X-RAY DIGITAL CAMERA CXDI-11
- K982639 — SPIFE URINE IFE
- K982760 — COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
- K982790 — QUANTA LITE H. PYLORI IGG ELISA
- K982801 — AUTO-LYTE PCP EIA, MODEL #1254U
- K982838 — CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
- K982855 — DIGIRAD 2020TC SPECT IMAGING SYSTEM
- K982857 — HELAX-IMCON, VERSION 1.0
- K982955 — SILHOUETTE VR
- K983083 — QUANTA LITE RF IGG ELISA
- K983084 — QUANTA LITE RF IGA ELISA
Data sourced from openFDA. This site is unofficial and independent of the FDA.