FDA 510(k) clearances — page 1004
clearances on record, most recent first.
Clearances — page 1004
100,301–100,400 of 176,637- K953644 — VOLAR DISTAL RADIUS PLATE
- K953777 — SYNTHES WIRE MOUNT
- K953806 — SYNTHES (USA) MIDFACIAL SYSTEM
- K954351 — SERIES 50XM
- K954385 — SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
- K954429 — KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
- K954856 — CANNULATED FEMORAL NAIL
- K954867 — IONOSIT SEAL
- K954988 — CRYSTALLESSENCE
- K955057 — MODEL 1100 COLD THERAPY DEVICE
- K955417 — VITAL PAK
- K955619 — 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
- K955701 — NIGHTGUARD DIAGNOSTIC APPLIANCE
- K955778 — NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
- K960222 — PERCUTANEOUS ENDOSCOPIC DISCECTOMY
- K960371 — INTERPORE THREADED IMPLANT
- K960828 — POS-T-VAC B-10 BAND KIT
- K950943 — ULTRA EASE
- K953391 — TREATMENT MANAGEMENT SYSTEM
- K953821 — BIOCOR 200 HARDSHELL VENOUS RESERVIOR
- K954394 — AESCULAP VENTRICULOSCOPE SYSTEM
- K954704 — VS-200 VIDEO SIGMOIDOSCOPE
- K954938 — DISPOSABLE NEUROVIEW OPERATING SHEATH
- K955025 — AXSYM PROGESTERONE
- K955050 — JETSTREAM CAVITY PREPARATION SYSTEM
- K955262 — TRUZONE PEAK FLOW METER
- K955588 — VASCUTEK GRAFT SIZER SET
- K960031 — AUDIOFLEX 120
- K960155 — UNITRON MODEL SOUND F/XP
- K960229 — RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
- K960284 — OTICON /PRIMOFOCUS (PF)
- K960326 — FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM
- K960473 — AESCULAP POWER SYSTEM HANDPIECE
- K944458 — ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
- K951514 — SSC MODEL 4000 SERIES
- K953838 — MYOCARDIAL PROTECTION SYSTEM
- K954095 — MEDICOOL (MODIFICATON)
- K954496 — FRONTLINE COCAINE
- K954497 — FRONTLINE CANNABIS
- K954498 — FRONTLINE OPIATES
- K954747 — NIOMED BARRIER GOWNS
- K955481 — THERATEST KIT (MODIFICATION)
- K955594 — SAFELINE I.V. BAG ACCESS DEVICE
- K955595 — SAFELINE MULTIDOSE VIAL ADAPTER
- K955656 — NORTH STATE PLASTICS AEROSOL TEE
- K955670 — DERMATOUCH LATEX GLOVES
- K955671 — RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
- K955903 — SELFCARE EARLY PREGNANCY TEST
- K960009 — STORZ S2050 SERIES BIPOLAR FORCEPS
- K960123 — SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM
- K960124 — SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM
- K960125 — SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM
- K960126 — SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM
- K960127 — SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM
- K960132 — SAS SALMONELLA H U ANTISERUM
- K960134 — SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM
- K960135 — SAS SALMONELLA H M ANTISERUM
- K960136 — SAS SALMONELLA H P ANTISERUM
- K960137 — SAS SALMONELLA H Z10 ANTISERUM
- K960138 — SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM
- K960140 — SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM
- K960142 — SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM
- K960145 — SAS SALMONELLA 0 FACTOR 27 ANTISERUM
- K960149 — SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM
- K960150 — SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM
- K960152 — SAS SALMONELLA 0 FACTOR 12 ANTISERUM
- K960153 — SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM
- K960161 — SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM
- K960162 — SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM
- K960163 — SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM
- K960458 — SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM
- K960459 — SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM
- K960460 — SAS SALMONELLA O FACTOR 46 ANTISERUM
- K960462 — SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM
- K960463 — SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM
- K960465 — SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM
- K960550 — ACTIVE T3 RIA
- K960551 — DSL ACTIVE HUMAN GROWTH HORMONE ELISA
- K931647 — PHOENIX 4.0 MM HA COATED DENTAL IMPLANT
- K943403 — CONDOR ULTRASONIC INSERTS
- K952536 — SONO 5
- K955559 — COROMETRICS FETAL MOVEMENT DETECTION KIT
- K955655 — MIDWEST ONE
- K955731 — OSTEONICS SHOULDER HUMERAL COMPONENTS
- K955892 — HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY
- K960181 — VERSION 3.7 OPERATING SYSTEM SOFTWARE
- K960554 — DETACHATIP THORACOSCOPIC SCISSORS
- K945627 — PIKOS LP 01, PIKOS LP E01
- K951592 — BETATRANS I AND II
- K952042 — TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
- K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
- K953850 — REDOX
- K954816 — STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
- K955540 — HAND HELD ATLAS INSTRUMENT
- K955554 — HEMO-VALVE
- K955676 — SYNCHRON SYSTEMS METHAQUALONE REAGENT
- K955710 — J.B.S. T.T.A SCREW
- K955768 — BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
- K955837 — CANNULATED PLUS HIP SCREW (STERILE)
- K955933 — BUFFARD CREATION (SUNGLASSES)
Data sourced from openFDA. This site is unofficial and independent of the FDA.