FDA 510(k) clearances — page 835
clearances on record, most recent first.
Clearances — page 835
83,401–83,500 of 176,637- K001262 — THERMAL CAUTERY FORCEPS
- K001273 — STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
- K001507 — MICROPERFORATION INSTRUMENT
- K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
- K001660 — MALLORY HEAD MODULAR CALCAR
- K001713 — HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
- K994209 — STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
- K000237 — EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
- K000627 — SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
- K000981 — CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
- K001012 — DIGITAL INTEGRATION SYSTEM, DIS2000
- K001113 — IVC THREE BLASTOCYST MEDIUM, CAT # 2007
- K001309 — HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
- K001326 — NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
- K001475 — HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR
- K001485 — HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
- K001584 — METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT
- K001620 — METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN
- K001762 — PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
- K992532 — VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
- K000072 — DORNIER MEDILAS D SKINPULSE
- K000687 — THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
- K001252 — MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
- K001284 — STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
- K001343 — EUDERMIC PF POWDER-FREE SURGICAL GLOVES
- K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
- K001529 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA
- K001534 — PINNACLE ACETABULAR SYSTEM
- K001549 — MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
- K001594 — 3.5 MM LAPAROSCOPE (LG100, LG103)
- K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
- K993518 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL
- K000336 — RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
- K000358 — MULTI ADJUSTABLE FACE MASK
- K000377 — MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
- K001034 — MODEL APS ALTERNANS PROCESSING SYSTEM
- K001114 — 3M QUIK TEMP TEMPORIZATION MATERIAL
- K001178 — CEDIA DAU 6-ACETYLMORPHINE ASSAY
- K001210 — HI-RES 9000 PHASED ARRAY CAROTID COIL
- K001287 — EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
- K001331 — SYNERGY HEAD/NECK COIL
- K001474 — TERUMO U-100 INSULIN SYRING
- K001488 — NARKOMED MRI , NM-MRI
- K001557 — LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
- K001574 — DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
- K993316 — UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
- K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES
- K993697 — DELFIA NEONATAL IRT KIT
- K993701 — PHARMASEED, MODEL BT-125-2
- K994199 — VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
- K000747 — UNIVEC TWO PIECE SYRINGE
- K000792 — CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
- K000798 — TALON BALLOON DILATION CATHETER
- K000813 — FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
- K000815 — AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
- K000817 — OMEGA II MODULAR TOTAL HIP SYSTEM
- K000836 — BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
- K000842 — CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
- K000904 — PENADAPT 10
- K000931 — AU5 ULTRASOUND IMAGING SYSTEM
- K000989 — SPERM WASH MEDIUM, CAT# 2003/2005
- K001046 — BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
- K001261 — L720 EXAMINATION CHAIR
- K001313 — AIRDENT II CS
- K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM
- K001546 — ALLON 2001
- K001602 — DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
- K991137 — ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
- K992980 — ENGAGE JAW INSERTS
- K994074 — TRI-BALL
- K000492 — MDA D-DIMER
- K000535 — QUANTA LITE LKM-1 ELISA
- K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
- K001159 — HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
- K001161 — ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
- K001192 — SELF ADHERING NAVIGUS GUIDE
- K001393 — THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
- K001436 — AGILENT M2636A TELEMON MONITOR
- K001437 — ENSITE 3000 SYSTEM, MODEL EE3000
- K001454 — SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
- K001487 — HARDYDISK CINOXACIN, 100 MCG
- K001548 — MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
- K984376 — ENDOR 2000
- K992221 — ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
- K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
- K992932 — CIPA (ADULTS) CIPI (INFANTS)
- K993066 — WINDOW CERVICAL DYNAMIC PLATE SYSTEM
- K001036 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
- K991206 — BONASSE CONTACT LENS CASE
- K992404 — THE WAND
- K992835 — C.S.O. TONOMETER
- K000001 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
- K000744 — MEDTRONIC AVE BRIDGE X3 STENT
- K000767 — MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
- K000820 — AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
- K000831 — STAT-SHELL DISPOSABLE SP02 SENSOR
- K000882 — DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
- K000998 — OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES
- K001597 — CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
- K990435 — BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
Data sourced from openFDA. This site is unofficial and independent of the FDA.