FDA 510(k) clearances — page 1028
clearances on record, most recent first.
Clearances — page 1028
102,701–102,800 of 176,637- K953918 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K953920 — REVERT SUNGLASSES & POLAR SUNGLASSES
- K953947 — SUNGLASSES
- K953960 — HEARING AID (ALL-IN-THE-EAR)
- K953989 — SUNGLASSES
- K953993 — TYMPASNOSTOMY TUBE
- K954075 — YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.
- K954155 — GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
- K943244 — DEUCE
- K952973 — THE TULIP MONO-POLAR CAUTERY SPATULA
- K953622 — PTT 6200 ELEVATION THERAPY TABLE
- K954011 — FASCIA CLOSURE DEVICE
- K924387 — INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS
- K935890 — ZETAPLUS (PUTTY)
- K936073 — ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS
- K936089 — COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
- K936145 — COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY
- K936251 — COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
- K936252 — COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
- K936253 — COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
- K936254 — COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
- K940018 — POLIOVIRUS 1 MONOCLONAL ANTIBODY
- K940363 — ENTEROVIRUS 70 MONCLONAL ANTIBODY
- K940471 — COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES
- K940472 — COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY
- K941801 — ANALGRAPH
- K944553 — PRESSURE SENSING SCOPE SHEATH SYSTEM
- K945746 — GAMBRO LUNDIA 94-500 DIALYZER
- K945747 — GAMBRO LUNDIA 94-600 DIALYZER
- K950960 — REDDY ILLUMINATOR
- K951256 — DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
- K951565 — INNOVASIVE DEVICES ROTATOR CUFF FASTENER
- K951595 — ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
- K951725 — OSTEONICS SPINAL SYSTEM
- K951990 — LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE
- K952251 — IMMULITE HCG HIGH LEVEL CONTROL MODULE
- K952252 — ADP REAGENT, MODIFIED
- K952271 — GENESIS CONSTRAINED SYSTEM (GCS)
- K952615 — WAKO AUTOKIT APO A1
- K952629 — NEXFLEX TOTAL HIP SYSTEM
- K952630 — DISPOSABLE BIOPSY FORCEP
- K952639 — DISPOSABLE TOOTHED GRASPING FORCEP
- K952730 — HOFFMANN II EXTERNAL FIXATION SYSTEM
- K952810 — DOSI-FLOW, MODELS 20 & 30
- K952855 — PC-LOCK
- K952873 — MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
- K952930 — DENTRAY II PLUS TRAY ADHESIVE
- K953017 — LOW PROFILE TITANIUM MODEL CATALOG #1003
- K953018 — UNI-SITE
- K953025 — SLT 28MM XXL FEMORAL HEAD
- K953070 — WOUNDFOAM 4 X 4
- K953123 — QUIK-STITCH
- K953131 — EXUSORB STERILE ABSORBENT
- K953167 — ULTRACID DISINFECTING SOLOUTION
- K953168 — ULTRACID F DISINFECTING SOLUTION
- K953331 — COMBINATION KIT
- K953342 — TMR48
- K953353 — UROVISION JANUS
- K953369 — STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW
- K953375 — NG SECURE
- K953496 — ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES
- K953498 — OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL
- K953831 — N 800 HF
- K953880 — BIOPSY NEEDLE
- K953923 — URESIL INTRODUCING NEEDLE
- K953962 — FORCEPS
- K944133 — MTB 1043 TREATMENT BOOTH
- K944362 — HEARTCARD CARDIAC EVENT MONITOR
- K945246 — PREVENTOR AND PROTECTOR LATEX CONDOMS
- K951250 — KARL STORZ SUCTION CATHETERS
- K952101 — MARQUETTE DEFIB ELECTRODES
- K953231 — PPMI-(XXX) AND PPMO-(XXX)
- K953507 — TYPE 1 & 2 (HUMIDAIR I & II)
- K953592 — REVOLUTION BOND
- K953859 — BOND-IT DUAL CURE ACTIVATOR
- K946196 — TROPICAIR CONVECTIVE WARING SYSTEM
- K950359 — KONICA LASER IMAGER LI-21
- K950376 — PARKER MODEL PM
- K950377 — PARKER MODEL PE
- K950476 — DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM
- K950881 — PHACO TIP
- K951671 — OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
- K951750 — GLUCOSE TEST ITEM NUMBER 97375/94
- K952037 — 3 LPM OXYGEN CONCENTRATOR
- K952086 — TROPICAIR CONVECTIVE WARMING BLANKETS
- K952778 — CHESHIRE
- K952919 — URINARY METANEPHRINE KIT
- K952949 — ACETAMINOPHEN ASSAY
- K953370 — KARL STORZ ENT SHAVER
- K953724 — CRONEX RADIATION THERAPY CASSETTE
- K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE
- K953849 — PRISM ELECTROSCOPE
- K953860 — HICHEM ISE DILUENT KIT 70008
- K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009
- K953862 — HICHEM ISEKCI SOLUTION KIT 70010
- K953863 — HICHEM ISE STANDARDS KIT 70011
- K950415 — FLUOROSCAN NEONATAL
- K951708 — ELSA-HCT
- K952116 — COVER GOWN
- K952307 — BIOSCAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.