FDA 510(k) clearances — page 1022
clearances on record, most recent first.
Clearances — page 1022
102,101–102,200 of 175,890- K952815 — DUPONT LIPASE CALIBRATOR
- K953069 — AMERIMED AS110
- K953395 — SYNERMED CALCIUM REAGENT KIT
- K935475 — QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
- K935554 — QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
- K941362 — BONE MINERAL DENSITOMETER
- K944724 — HEALTH IMAGE INC. HI STAR
- K950624 — HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
- K952459 — MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
- K952811 — 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS
- K952812 — 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS
- K953547 — MANAN NEPHROSTOMY DRAINAGE CATHETER
- K940537 — KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
- K944931 — BECTON DICKINSON BLUNT STEEL CANNULA
- K950416 — BAIR HUGGER MODEL 600 UNIT, BLANKETS
- K951299 — EASY PNEUMATIC CROWN AND BRIDGE REMOVER
- K951814 — TRIUMPH-1 PORT
- K952274 — CHEMOGUARD, P2 HIRISK
- K952422 — ELASTIC IMPRESSION CREAM
- K952562 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE
- K953013 — MEROCEL REINFORCED SILICONE SHEETS
- K953034 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
- K953103 — LAPPING TOOL KIT
- K953291 — QUANTA LITE ACA SCREEN (HRP)
- K953383 — WYNTEK OSOM HCG-URINE TEST
- K953440 — ELLMAN LAPTRODE
- K953527 — PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS
- K930665 — CENTURY BATHING SYSTEM
- K944305 — FRIEDRICH ELECTRONIC AIR CLEANER
- K944393 — STRYKER STERI-SHIELD SURGICAL APPAREL
- K944492 — DIALYZER REPROCESSING SYSTEM
- K944713 — W&H MICRO AIR MOTOR LT25
- K945480 — MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
- K946140 — PRG BUTTON
- K950596 — GDLH POSTERIOR SPINAL SYSTEM
- K950825 — AM-YAG
- K951018 — LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER
- K951020 — TRI-CEN GERMICIDAL DETERGENT
- K951974 — IMAGYN ENDOSCOPE SHEATH
- K952336 — DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
- K952405 — CITRACE HOSPITAL GERMICIDAL DEODORIZER
- K952512 — CAPNO-FLO REGULATOR, CAPNO-FLO
- K952554 — SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM
- K952618 — BIO-OSS
- K952619 — BIO-OSS CERAMIC
- K952662 — COMP=FLOW
- K952705 — SPIRIT RIDGE NASAL IMPLANT
- K952706 — SPIRIT RIDGE SILICONE CARVING BLOCK
- K952707 — SILICONE ELASTOMER MALAR IMPLANT
- K952708 — PECTORALIS IMPLANT
- K952709 — PROTHESIS, CHIN, INTERNAL
- K952792 — PADLESS ELECTROSURGICAL PENCIL
- K952916 — SHIATSU MASTER MASSAGER CUSHION
- K952974 — QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER)
- K952981 — FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
- K952993 — SAFESKIN SUPRA
- K953015 — SAFESKIN SUPRA
- K953026 — MINIPIEZON
- K953074 — MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
- K953119 — BOSWORTH RESIN II
- K953174 — MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY
- K953206 — DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
- K953243 — LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH
- K953501 — ADI STERILE GAUZE SPONGES
- K953525 — ULTRADENT FLOWABLE COMPOSITE
- K953631 — SNIP INPUT COMPRESSION CLASS A
- K953646 — UNITRON MODEL IKON AOHPL
- K953816 — DCURASOL GEL WOUND DRESSING
- K941118 — HEAD IMMOBILIZATION APPARATUS
- K941308 — NEWPORT ELECTRONIC MANOMETER
- K942889 — SB ANCHOR
- K943531 — OXYLOG 2000
- K943725 — UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
- K944711 — W&H AIR MOTOR A25
- K944712 — W&H MICRO MOTOR E25 (WITHOUT LIGHT)
- K944714 — W&H CORSAIR SCALER
- K950194 — TAMPON, UNTREATED
- K950742 — CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
- K950824 — STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
- K950955 — PARAGON POSTERIOR SPINAL SYSTEM
- K951232 — EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
- K951320 — AURAFLEX TG-AB AND TPO-AB
- K951510 — ACE BONE SCREW TACKING KIT
- K952291 — GAMMACELL 3000 ELAN
- K952327 — SMARTSAT PULSE OXIMETRY ANALYZER
- K952480 — ORIMS DIGITAL ANGIOGRAPHY SYSTEM
- K952508 — FLOW-THERME, WISAP #7642
- K952607 — AURAFLEX TPO-AB
- K952626 — MAPWIRE J-TIP SENSOR GUIDEWIRE
- K952670 — CUPRALLOY
- K953109 — HAND EXTRACTOR HECTOR
- K953217 — PULPDENT TOUCHDOWN
- K953272 — PULPDENT DENTASTIC II
- K953301 — DENTASTIC ONE-STEP
- K953344 — DEGUBOND ULTRA
- K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
- K953540 — EEE
- K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
- K953619 — WARM N WET HME W/LUER ADAPTER
- K953620 — WARM N WET HMEF W/LUER ADAPTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.