FDA 510(k) clearances — page 717
clearances on record, most recent first.
Clearances — page 717
71,601–71,700 of 175,825- K030908 — DEROYAL SURGICAL DRAPES BACKTABLE COVER
- K031548 — LED HEADLIGHT
- K031549 — SOLID STATE LAMP [LED] HEADLIGHT
- K031562 — RAMSOFT PACS, MODEL 3.0
- K031636 — CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
- K031923 — ULTRASITE VALVE
- K032001 — POLY Q (GARANT L, PENTA M, PENTA H)
- K032228 — LORENZ 2.4 SELF DRILLING SCREWS
- K032265 — CD HORIZON SPINAL SYSTEM
- K024359 — VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
- K030109 — ELECTROPHYSIOLOGY CATHETER
- K030302 — HBS HEADLESS BONE SCREW
- K030369 — OPUS SPINAL SYSTEM
- K030529 — LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
- K030596 — IMMUNICON CELLSAVE PRESERVATIVE TUBE
- K031428 — SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
- K031608 — RANDOX LIQUID PROTEIN CALIBRATOR
- K031654 — SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
- K031702 — REFLEX ANTERIOR CERVICAL PLATE SYSTEM
- K031744 — OMNIFIT HFX HIP STEM SERIES
- K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
- K031900 — HANDMASTER
- K032015 — EMBRYON ULTRASOUND NEEDLE GUIDE
- K032017 — LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
- K032050 — PERIVAC KIT
- K032095 — INTERPORE CROSS CEMENT RESTRICTOR
- K032097 — DEPUY ACE VERSANAIL TIBIAL NAIL
- K032117 — STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
- K032142 — DATACAPTOR
- K032162 — ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
- K032197 — TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
- K032206 — PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
- K032215 — VKS/TC-PLUS REVISION KNEE
- K032224 — BIORCI SCREW
- K032244 — GAMMA 3 NAIL SYSTEM
- K032264 — MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
- K032339 — CARDIOVATIONS PORTABLE VIDEO SYSTEM
- K023735 — LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
- K030316 — AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
- K031158 — SWIFT 2.0, MODEL 132.001
- K031349 — OTP 1.2
- K031432 — KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
- K031544 — HEATER COOLER UNIT, MODEL HCU 30
- K031586 — CORRESTORE PATCH SYSTEM
- K031630 — BIFURCATED ALLERGY SKIN TESTING NEEDLE
- K031672 — SPINAL CONCEPTS, INC. INFIX SYSTEM
- K031778 — PRACTICEBUILDER 1-2-3
- K031924 — VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
- K031992 — ECHELON MICRO CATHETER, MODEL 105-5091
- K032014 — N LATEX IGM
- K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
- K030119 — NANMA ADJUSTABLE CONSTRICTION RING
- K030277 — SOFT-CELL DUAL LUMEN CATHETERS
- K031354 — EBI OMEGA21 SPINAL FIXATION SYSTEM
- K031401 — FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
- K031462 — THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
- K031539 — HEMOGLOBIN A1C REAGENT SET
- K031577 — LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS
- K031683 — TOX AMMONIA CALIBRATOR
- K031693 — MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
- K031706 — CARDIOQ, MODEL 9051-7005
- K031779 — CADSTREAM
- K031856 — PRECISET TDM I AND PRECISET TDM II CALIBRATORS
- K031943 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML
- K032047 — TRI-LOOP MICROWAVE ABLATION PROBE
- K032152 — BENCO ADMIX
- K032281 — SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
- K032329 — SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
- K030219 — DIGITAL TEMPERATURE MONITOR; MODEL KY-01
- K030795 — LIFESYNE SYSTEMS
- K031282 — OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
- K031461 — CARRIER TIPS
- K031472 — ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
- K031717 — ELECSYS SHBG IMMUNOASSAY
- K031752 — COLTOSOL F
- K031775 — PRECISET DAT PLUS I CALIBRATORS
- K031786 — TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
- K031830 — SAFEPRO PLUS SAFETY SYRINGE
- K031915 — PULPDENT ETCH-RITE ROYALE
- K032336 — TINA-QUANT CRP (LATEX)
- K032346 — UNITY NETWORK IS PATIENT VIEWER
- K023279 — GLUCOLEADER VALUE
- K023548 — PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
- K031435 — BONESOURCE BVF
- K031574 — SQUEEZE-EASE MAMMOGRAPHY CUSHION
- K031759 — ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD
- K012715 — HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
- K014241 — COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
- K024283 — CARDIODIRECT, MODELS 12M, 12I, 12S
- K030487 — R 72
- K030517 — BALL RECORDING ELECTRODE/STIMULATION PROBE
- K031049 — GUGLIELMI DETACHABLE COIL (GDC)
- K031323 — DBT, DYNAMIC BUBBLE TRAP
- K031387 — ISOLETTE INFANT INCUBATOR, MODEL C2000E
- K031451 — XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
- K031483 — MEDRAD MANUAL SYRINGE LOADER
- K031532 — SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR
- K031561 — CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
- K031578 — MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
- K031582 — WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
Data sourced from openFDA. This site is unofficial and independent of the FDA.