FDA 510(k) clearances — page 725
clearances on record, most recent first.
Clearances — page 725
72,401–72,500 of 175,825- K030508 — DEPILASE TRIO LASE LASER SYSTEM
- K030518 — AMERITEK SURE-POINT TRACKER SYSTEM
- K030527 — LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
- K030554 — CALLOS
- K030820 — EVERSTICK POST
- K031053 — SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
- K031134 — DISPOSABLE POWDERED VINYL EXAM GLOVES
- K031272 — C.T.M. MOBILITY SCOOTER, MODEL HS-120
- K031398 — IS-1 HEMOSTASIS VALVE, MODEL 6799
- K031407 — ROSS EMBRACE ENTERAL PUMP
- K030631 — ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
- K030952 — DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421
- K031122 — HEMOSIL FACTOR X DEFICIENT PLASMA
- K031285 — MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
- K023857 — PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
- K023908 — INTERPORE CROSS CEMENT RESTRICTOR
- K030714 — PEAK MOTUS
- K030932 — CD HORIZON SPINAL SYSTEM
- K030986 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML
- K031078 — EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS
- K031080 — EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS
- K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
- K031218 — MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
- K022506 — MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
- K023594 — TENO FIX
- K030840 — MODIFICATION TO HORIZON SPINAL SYSTEM
- K030921 — COLLAGEN TOPICAL WOUND DRESSING
- K030925 — PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
- K030947 — ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
- K031069 — SURGISIS NERVE CUFF
- K031295 — BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
- K031332 — BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
- K031343 — TPSA FLEX REAGENT CARTRIDGE
- K021944 — COZART EIA COTININE URINE KIT
- K023733 — COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
- K030480 — L600 HAIR REMOVAL
- K030505 — CAPIOX CARDIOTOMY RESERVOIR
- K030510 — DEPILASE TWIN YAG LASER SYSTEM
- K030512 — GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K030549 — HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG
- K030748 — AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
- K030917 — GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
- K031086 — CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
- K031123 — CODMAN BACTISEAL BARIUM STRIPED CATHETERS
- K031149 — OLYMPIC CFM 6000
- K031168 — MATRIX STRETCH RESISTANT DETACHABLE COIL
- K031277 — JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
- K031300 — IBC FLOPUMP WITH GBS COATING
- K022834 — DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
- K023478 — INBODY AP1 BODY COMPOSITION ANALYZER
- K023740 — SYREX PRE-FILLED SYRINGE
- K030209 — MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
- K031037 — EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
- K031290 — MODIFICATION TO EASYS TRANSVERSE CONNECTION
- K031333 — PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
- K031396 — ADVANTAGE WORKSTATION PASTING 1.1
- K030453 — COOLTOUCH ND: YAG LASER SYSTEM
- K030513 — CELL-DYN 1800 SYSTEM
- K030775 — AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
- K030873 — RANDOX AMMONIA
- K031259 — MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
- K031299 — ELECSYS LH CALSET II
- K031330 — MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K021230 — HERO
- K021813 — HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM
- K022662 — DIATEK CANNON-CATHETER, MODEL CC5500
- K022978 — STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
- K023338 — PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2
- K023424 — IGI-SYSTEM
- K030300 — OPAQUE HERRICK LACRIMAL PLUG
- K030417 — DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
- K030423 — POWERLITE 600 EP SYSTEM
- K030443 — MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
- K030448 — OSTEOMED 2.0 LOCKING PLATES AND SCREWS
- K030469 — LAPAROSHIELD CONDITIONED INSUFFLATION SET
- K030506 — DEPILASE YAG LASE PLUS LASER SYSTEM
- K030561 — MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
- K030680 — SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
- K030743 — ETCHANT 40%
- K030776 — MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
- K030907 — STACKED ABR FOR NAVIGATOR PRO
- K030931 — C3 PATIENT MONITOR
- K031008 — AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
- K031156 — NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
- K031224 — SMARTXIDE
- K031289 — QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
- K031293 — SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
- K031358 — TRANSVAGINAL DOPPLER PROBE
- K030439 — HEADFIX
- K030573 — BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
- K031056 — MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
- K031089 — GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
- K023820 — CO2 CLIP
- K030588 — ARTEGRAL AND POLYSTAR SELECTION
- K030632 — PD CASTA-H
- K014199 — SURGICAL SIMPLEX P WITH TOBRAMYCIN
- K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
- K022389 — READI-LOAD SYSTEM, MODEL PSS 1820RL
- K023253 — PEDIATRIC CENTRAL VENOUS CATHETER KIT
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