FDA 510(k) clearances — page 955
clearances on record, most recent first.
Clearances — page 955
95,401–95,500 of 175,890- K964712 — PRISM XPVT SYSTEM (210823)
- K964719 — HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
- K964750 — EAGLE 4000 PATIENT MONITOR
- K964751 — CERALAS DIODE LASER SYSTEM (CERALAS D2)
- K964770 — COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
- K964773 — DENTEMP ONE STEP
- K964994 — CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
- K965249 — SPYGLASS ANGIOGRAPHIC CATHETER
- K944438 — HEMAGEN CMV IGG KIT
- K962475 — ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
- K962517 — MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
- K963000 — MAXI LD PTA BALLOON CATHETER
- K963207 — QUICKPAC II ONE STEP MARIJUANA (THC) TEST
- K963544 — SUPREME II METER
- K963676 — PRECISION G BLOOD GLUCOSE TESTING SYSTEM
- K964037 — FLEXIBLE CYSTOSCOPE
- K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
- K964452 — HEMATACHEK
- K964633 — ACCUPACK PREGNANCY TEST
- K964696 — SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
- K964913 — IRON REAGENT
- K964963 — LYPHOCHEK COAGULATION CONTROL
- K964982 — VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
- K965036 — THE ADVANCED OSMOMETER (3900)
- K965064 — ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
- K965099 — ACCUMETER H. PYLORI TEST
- K965114 — TUMOR MARKER CONTROL
- K965116 — ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
- K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN
- K970198 — IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
- K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
- K940942 — COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
- K953978 — ANTERIOR DYNAMIZED SYSTEM
- K961073 — ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
- K962702 — SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA
- K964305 — NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
- K964665 — VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
- K964760 — DORNIER MEDILAS FIBER TOME LASER
- K964795 — CEMENTED CALCAR REPLACEMENT FEMORAL STEM
- K964833 — RMI DUAL FLUID IRRIGATING SYRINGE
- K965029 — STABLELOC II EXTERNAL FIXATOR
- K970110 — BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
- K970346 — PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
- K955455 — BAERVELT PARS PLANA GLAUCOMA IMPLANT
- K960363 — BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143
- K961142 — STRATEC LIA II ANALYZER
- K963640 — OLYMPUS ACID PHOSPHATASE REAGENT
- K964486 — ACCUCURE 3000
- K964648 — PROTECT ALL BLOOD PRESSURE CUFF COVER
- K964668 — MODELS EXL AND EXS EXTREMITY COIL SET
- K964857 — RAPISEAL PATCH
- K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDES
- K965109 — ELECSYS ESTRADIOL ASSAY
- K965111 — STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
- K965134 — ALT/SGPT
- K965250 — SAS SERUM/URINE HCG
- K965253 — SAS PREGNANCY STRIP
- K970008 — ADVANCED QUALITY PREGNANCY TEST
- K970066 — UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
- K970389 — THYROID CALIBRATOR
- K941604 — VENTANA ANTI-CD4 PRIMARY ANTIBODY
- K941784 — VENTANA ANTI-CD8 PRIMARY ANTIBODY
- K960640 — S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
- K960727 — EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
- K961246 — SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
- K961252 — DSXL DIFFUSION SPIROMETER
- K963131 — GRASEBY ANDERSEN'S, INTEGRITY S700
- K963441 — BALDUR VINYL POWDERED GLOVES
- K963505 — TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
- K963981 — VYGON BIONECTOR WITH EXTENSION SET
- K964171 — VASOVIEW BALLOON DISSECTION SYSTEM
- K964358 — AMSEAL SURGICAL FACE MASK
- K964543 — INFRASONICS ADULT VENTILATOR TRENDING OPTION
- K964598 — TRUSTEX COLA FLAVORD CONDOM
- K964599 — TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
- K964653 — OASIS HUMIDIFIER
- K964658 — OASIS
- K964684 — SOFTOUCH
- K964765 — CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
- K964800 — JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
- K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT
- K964955 — FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
- K965086 — CYGNUS ELECTROSURGICAL TIP CLEANER
- K965138 — DENTINSENSE B/C
- K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
- K965248 — BEMIS TWO GALLON SHARPS CONTAINER
- K970085 — SEALITE SCIENCES AQUALITE FSH
- K970186 — GI SUPPLY PARACENTESIS PUMP
- K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT
- K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER
- K970311 — BENTLEY MANUALLY OPERATED WHEELCHAIR
- K970343 — MMB METHOD
- K963045 — SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
- K963148 — NEXGEN COMPLETE KNEE SOLUTION
- K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER
- K963466 — PEDIATRIC LIMB HOLDER
- K963729 — SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
- K963940 — EXETER MESH
- K964079 — SPEEDBAND MULTIPLE BAND LIGATOR
- K964591 — TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.