FDA 510(k) clearances — page 1022
clearances on record, most recent first.
Clearances — page 1022
102,101–102,200 of 176,637- K951025 — PISTON SYRINGE
- K951483 — CPR MICROMASK
- K951496 — CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
- K951627 — INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM
- K952117 — EPILATOR
- K952474 — EAGLE 3000 PATIENT MONITOR
- K952628 — ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS
- K953415 — 6200 VITAL SIGNS MONITOR
- K953572 — ELX800UV
- K953732 — TECA PREMIERE
- K953749 — MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS
- K953986 — POWDERFREE LATEX GLOVE
- K954189 — EASI-JECTOR CONTROL SYSTEM
- K954299 — BUHLMANN ANGIOSTENSIN II RIA
- K954373 — AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
- K954374 — AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
- K954561 — XENON NOPPVA
- K954643 — TRY-IN GEL
- K943101 — GALVANIC SKIN RESPONSE DEVICE
- K945983 — BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
- K951117 — LIHTAN 532 LASER
- K952611 — STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
- K952736 — PERCENT OXYGEN SENSOR
- K953294 — CANDELA CRYOSYSTEM CS-5
- K953371 — LUMISYS DICOM TOOKLIT
- K953533 — RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
- K953554 — NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES
- K953602 — SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
- K953869 — POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE
- K953889 — AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
- K953910 — PHILIPS BV 300 SERIES
- K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
- K954252 — EASY BREATHING NASAL STRIPS
- K954263 — XE-LITE
- K954310 — BLA-800A
- K954345 — DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR
- K954484 — KODAK AUTOMIXER II PLUS
- K954526 — WIDEX SENSO DIGITAL (PX)
- K930530 — INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
- K935892 — INDURENT GEL
- K945445 — BOBES SLIT LAMP
- K950073 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
- K951665 — PP-SPF1 / PP-SPF2
- K951753 — MEDTEC AUTOBLOT 2000
- K952621 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K953262 — QD BILATERAL BREAST COIL
- K953359 — TRI-STAR UNIVERSAL I/A PHACO PAK
- K953382 — ACCUPUMP 901 (MODEL NUMBERS 50 & 100)
- K953468 — SONOGEL
- K953660 — PLUM XL INFUSION PUMP (MODIFICATION)
- K954108 — MODIFIED VERSAPORT
- K954324 — SNOR-X MOUTH GUARD
- K954341 — URODYNAMICS TUBING AND INFUSION SETS
- K954372 — AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
- K943412 — VENTURI VENTILATOR
- K950587 — ECOTABS
- K950750 — MEDELAS BREAST PUMP
- K950889 — ADEL 5000
- K951754 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
- K951769 — CRYOPRESS
- K951882 — ECO CHECK (ECOVALVE AND OXYGEN MONITOR)
- K952917 — STERI-OSS IMMEDIATE PLACEMENT IMPLANT
- K953089 — I-SPOUSE
- K953351 — SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS
- K953409 — LAPAROSCOPIC TROCAR
- K953691 — MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
- K953738 — ERBOTOM ICC 300
- K953949 — HUMIDIFIER & ACCESSORIES
- K954041 — G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)
- K954080 — SODEM HIGH SPEED SYSTEM
- K954273 — CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
- K954384 — WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
- K954461 — AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE
- K954520 — MICROSURGE VERESS NEEDLE
- K935456 — REGULUS MEASUREMENT UNIT
- K941342 — PAIN DOC
- K950305 — QTMICRO(TM) SYSTEM
- K950617 — SMART WAVE GS100
- K951363 — CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
- K951639 — COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
- K952488 — TRACE COBAS MIRA RANGE
- K952765 — DELWA-STAR PACIFIER THERMOMETER
- K953447 — PRECISIONIST THIRTY THOUSAND
- K953448 — ROCHE COBAS MICROS HEMATOLOGY ANALYZER
- K953593 — RUSCH TRACHEAL BRONCHIAL Y STENT
- K953655 — J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS
- K954044 — SIDEKICK POWER WHEELCHAIR
- K954117 — CUSTOMCARE SEATING SYSTEM
- K954261 — LANDEEZ ALL-TERRAIN WHEELCHAIR
- K954266 — STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
- K954321 — ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)
- K954344 — RUSSON INDUSTRIES FURNITURE QUALITY WHEELCHAIR
- K954364 — CAMEO HOME PREGNANCY TEST
- K954462 — POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES
- K941279 — LOWER BOWEL EVACUATION SYSTEM
- K944993 — IOLAB.SITE CD PHACOEMULSIFICATION MODULE
- K945506 — ACRYLIC DIPPED LATEX EXAMINATION GLOVES
- K945618 — GASTROINTESTINAL TUBES & ACCESSORIES
- K950854 — VITALOGRAPH 2110 SOFTWARE INTERFACE
- K951858 — TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
Data sourced from openFDA. This site is unofficial and independent of the FDA.