FDA 510(k) clearances — page 690
clearances on record, most recent first.
Clearances — page 690
68,901–69,000 of 176,637- K042103 — NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
- K041262 — DURALITE-GL
- K041445 — IMMUNOCARD STAT! RSV MODEL #750630
- K042044 — ACUSON CV70 CARDIOVASCULAR SYSTEM
- K042124 — DENFIL
- K032192 — PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
- K033027 — SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
- K033843 — SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
- K040307 — HANSON SCAR ADE
- K040314 — HEALICOLL
- K040717 — NUNC IVF MULTIDISH 4 WELLS NUNCLON
- K040792 — POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
- K041057 — FLO-RITE
- K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY
- K041202 — HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
- K041244 — POLYGRAM NET BIOFEEDBACK APPLICATION
- K041297 — POLYMEDCO OC LIGHT FOBT TEST
- K041320 — MODIFICATION TO NC-STAT
- K041503 — HOVERJACK AIR PATIENT LIFT DEVICE
- K041572 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML
- K041985 — XPS CURVED BUR
- K042022 — E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
- K033736 — MERCI RETRIEVER, MODELS 90065, 90066
- K040710 — TEGO NEEDLE FREE ACCESS ACCESS DEVICE
- K040745 — MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
- K040848 — EZ SMART
- K041266 — PEDIATRIC REFERENCE DATABASE
- K041334 — ALCOMATE, MODEL CA2000
- K041438 — ADVANCED D-DIMER ASSAY
- K041697 — TERUMO CIRCUIT CONNECTORS
- K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
- K041780 — NEW BRID
- K041948 — SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
- K042009 — MARK III PHASED ARRAY SHOULDER COIL
- K040651 — HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM
- K041049 — BINAXNOW INFLUENZA A & B TEST
- K041231 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
- K041264 — ELEKTA OY
- K041888 — CURVED PEEK TETRIS SPINAL IMPLANT
- K030774 — STIMULEN COLLAGEN
- K032954 — ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
- K033135 — STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
- K033648 — PERFORMANCE WATER TREATMENT SYSTEM
- K041076 — DELTA T
- K041197 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K041386 — RAVEN PROTEST - STEAM
- K041492 — ASTRA TECH IMPLANTS - DENTAL SYSTEM
- K041548 — SENTEC DIGITAL MONITOR MODEL #SDM
- K041555 — SECURVIEW DX SOFTCOPY WORKSTATION
- K041562 — CRYOTIP
- K041748 — AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
- K041831 — PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
- K041953 — VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
- K041956 — EMG - ESSENTIAL GAS MODULE, MODEL M1013A
- K042028 — VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
- K032884 — FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
- K040358 — XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
- K040637 — POWERHEART AED G3 PRO
- K041434 — C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
- K041504 — HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
- K041629 — LYSUS INFUSION SYSTEM
- K041689 — POLYURETHANE BLOOD PRESSURE CUFFS
- K041762 — FINISHING WIRE SUPPORTRAK
- K041809 — PERMANENT PACING LEAD, MODEL PY2
- K041827 — DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
- K041980 — MSI S-500L RF GENERATOR
- K041990 — FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP
- K042014 — DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400
- K030819 — PLASMAJET SYSTEM
- K032596 — STURDY MANUAL RESUSCITATOR
- K033580 — NEXFLEX TOTAL HIP SYSTEM
- K033587 — SILVERSEAL
- K040731 — STRYKER SPINE VERTEBRAL SPACER
- K041287 — VILEX BONE PLATE SYSTEM
- K041289 — TALUS OF VILEX (TOV)
- K041316 — ANTIMICROBIAL ALGINATE DRESSING
- K041517 — INFUSIONCATH
- K041589 — ARTHREX FIBERWIRE WITH SILK
- K041677 — KARMA SCOOTER, MODEL KS-747.2
- K041691 — CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
- K041721 — LVI AESTHETIC LASER
- K041752 — TEH LIN POWERED WHEELCHAIR, MDG-601
- K033178 — ULTRABIO
- K033399 — GEODESIC EEG SYSTEM SERIES 100
- K040082 — PORE-SI BONE GRAFT SUBSTITUTE
- K040798 — HES ULTRASONIC THERAPY APPLIANCE
- K041219 — ELECTRO
- K041415 — EVA TPN CONTAINER
- K041519 — MODIFICATION TO: ON-BOARD IMAGER DEVICE
- K041886 — PROVISO
- K041915 — HEMO-DOP
- K033685 — NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
- K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
- K040343 — TEMP F
- K041263 — NEUROGUIDE ANALYSIS SYSTEM
- K041384 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
- K041531 — ASAHI PTCA GUIDE WIRE CONFIANZA PRO
- K041710 — VERSAWAVE DENTAL ER:YAG LASER SYSTEM
- K041776 — PASCO MIC AND MIC/ID PANELS
- K041796 — PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.