FDA 510(k) clearances — page 911
clearances on record, most recent first.
Clearances — page 911
91,001–91,100 of 175,890- K972500 — TIR/TIJ AND POLYROX
- K972591 — HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
- K973282 — HANDI OXYGEN ANALYZER
- K973802 — SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
- K974192 — BIOSENSOR HOLTER MONITOR SYSTEM
- K974311 — VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
- K974546 — BIOSENSOR HOLTER MONITOR SYSTEM
- K974558 — SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
- K974614 — GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
- K974624 — ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
- K974625 — OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
- K974700 — MATRIX MT-MX3
- K974755 — DYNA VUE 3-D IMAGING PRODUCT
- K980075 — CYBERSONIC
- K980082 — J-TIP NEEDLESS INJECTOR
- K980097 — FLEXIGEL-G HYDROGEL WOUND DRESSING
- K980374 — IMPLANT SITE DILATORS
- K980461 — SPECTRUM DESIGNS CLEFT CHIN IMPLANT
- K980514 — CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
- K962903 — PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE
- K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
- K973523 — ACCUSTAT H. PYLORI ONE STEP TEST
- K974084 — GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
- K974538 — MENISCAL REPAIR DEVICE
- K974555 — SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)
- K974694 — IS-DSDNA TEST SYSTEM
- K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K974752 — IMTEC/BIOBARRIER MEMBRANE
- K974786 — PREPQUICK
- K980031 — ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
- K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT
- K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
- K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
- K980349 — QUICKPAC II ONE STEP BARBITURATE TEST
- K980381 — PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO
- K980414 — VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET
- K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
- K971028 — WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
- K971759 — MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
- K972324 — LEKSELL STEREOTACTIC SYSTEM
- K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
- K973357 — COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
- K974034 — PORTABLE INTENSIVE CARE UNIT
- K974313 — HYDROFERA SURGICAL SPEAR
- K974475 — THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
- K974525 — SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM
- K974563 — COLPO CUP CVC-2000
- K974599 — ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS)
- K974724 — SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
- K980032 — SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
- K980061 — EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
- K980093 — DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE
- K971348 — FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
- K971619 — MICROFUSE MEMBRANE INFUSION CATHETER
- K971710 — ULTRACON ULTRAFILTRATOR
- K972244 — NT2000
- K972321 — S3 MAST PUMP
- K972775 — FASTDAM
- K973197 — FIRE STICK
- K973409 — KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
- K973425 — THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
- K973758 — BIOSCREW ABSORBABLE INTERFERENCE SREW
- K973909 — KSEA ENDOTIP SYSTEM
- K974067 — FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
- K974082 — THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE
- K974504 — EPS
- K974506 — LSF HA COATED TRIAD TOTAL HIP SYSTEM
- K974556 — OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
- K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR
- K974856 — 3.25MM SIMPLER THREADED DENTAL IMPLANT
- K974857 — 4.0MM SIMPLER THREADED DENTAL IMPLANT
- K974900 — CYNOSURE PHOTOGENICA 532 LASER
- K980050 — MENTOR SKIN PROTECTION PAD
- K980156 — SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
- K980171 — DERMASENSE PLUS DISPERSIVE ELECTRODE
- K980229 — MSB TENS ELECTRODES (DISPOSABLE)
- K980281 — WELCH ALLYN XENON 300 LIGHT SOURCE
- K980366 — AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240
- K980418 — BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER
- K971592 — XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
- K971593 — SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
- K972877 — ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
- K972883 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
- K972900 — ULTRASAFE MODEL T200 INJECTOR
- K973000 — ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
- K973373 — PREVENT I
- K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
- K974495 — NEUROAMP EEG AMPLIFIER
- K974498 — STRATIS II
- K974764 — INTROSYTE CATHETER
- K980183 — PROMAX SURGICAL DRAPES AND COVERS
- K980509 — DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
- K973011 — BPX80 BIO-PUMP (BPX80)
- K973120 — READYCATH CATHETER
- K973269 — QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
- K973285 — D/SENSE-T
- K974132 — VOICE MASTER PROSTHESIS
- K974173 — ERECAID SYSTEM/STAY EREC SYSTEM
- K974253 — CPD COMMANDER
- K974256 — ECAT PET SCANNERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.