FDA 510(k) clearances — page 597
clearances on record, most recent first.
Clearances — page 597
59,601–59,700 of 176,637- K070966 — GSO GS1 SPINAL SYSTEM
- K071027 — TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE
- K071147 — NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
- K071183 — ALLEGRO OCULYZER
- K071300 — MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
- K071390 — WHEELCHAIR MODEL STS
- K071393 — JAZZ BLOOD GLUCOSE MONITORING SYSTEM
- K071714 — NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
- K071801 — VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
- K070465 — BUSSE EPIDURAL CATHETER
- K071288 — MODIFICATION TO KAVO QUATTROCARE
- K071292 — VIEW MD OFFICE SYSTEM, MODEL 41066.5540
- K071676 — EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
- K071735 — MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
- K071745 — BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
- K061495 — VR LUNG ELECTROSONOGRAPH
- K070346 — DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
- K070608 — SMARTEP, MODEL M010000
- K071163 — WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603
- K071381 — GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
- K071423 — MEDLINE LATEX FOLEY CATHETER
- K071550 — PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
- K071556 — SOMNOSCREEN EEG10-20
- K071665 — SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
- K071673 — ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032
- K071715 — ACUMED CONGRUENT BONE PLATE SYSTEM
- K071882 — MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
- K061934 — XTAC
- K070428 — MEDICOM SELF-SEALING STERILIZATION POUCH
- K070435 — DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
- K070461 — VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
- K071111 — NON-ABSORBABLE SILK SUTURE
- K071175 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K071260 — HERMES BOND 3
- K063710 — SATURN 9000
- K070299 — EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
- K070500 — BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
- K070936 — WELMED HYPODERMIC SYRINGE
- K071467 — VARISOURCE IX HDR AFTERLOADER
- K071494 — CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
- K062118 — POINTE 360
- K062981 — I-CHROMA CRP TEST
- K063069 — SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
- K063641 — PC-60, NON-INVASIVEPULSE OXIMETER
- K063805 — SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
- K070112 — RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
- K070132 — TRIPORE, MODELS HA, BP90, BP15
- K070183 — KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
- K070392 — MOSAIC LASER SYSTEM
- K070555 — ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
- K070577 — ON THE GO SHARPS
- K070581 — SILVER ALGINATE II WOUND DRESSING
- K070599 — CUSTOMIZED SOUND THERAPY (CST)
- K070631 — DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
- K070636 — AUTOVENT 4000 WITH CPAP
- K070704 — TRILOGY ANALYZER
- K070709 — ROCHE ELECSYS PTH TEST SYSTEM
- K070746 — RESTRAXX DATA CENTRE, MODEL R10
- K070852 — VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
- K071309 — BLUE MAX BALLOON DILATATION CATHETER
- K071322 — POWDER FREE LATEX EXAMINATION GLOVES
- K071354 — MEPILEX AG DRESSING
- K071664 — TRELLIS-6 PERIPHERAL INFUSION SYSTEM
- K071718 — TRILOGY LONGEVITY CONSTRAINED LINER
- K071721 — ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
- K071728 — MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
- K053095 — HONEY ALGINATE DRESSING
- K071285 — DIGITAL PULSE OXIMETER, MODEL 7500
- K071473 — MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
- K071634 — MODIFICATION TO:CONTOUR SE MICROSPHERES
- K071640 — VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
- K070253 — AXYA SUTURE WELDING SYSTEM AND KIT
- K070377 — GIRAFFE AND PANDA WARMER
- K070401 — ENDO-CHX
- K070578 — CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER
- K070611 — BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
- K070634 — SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110
- K070785 — DYNASTY ACETABULAR SYSTEM
- K070805 — ULTRAWAVE II EX 1320
- K070960 — NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
- K071182 — PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
- K071227 — CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15
- K071581 — BACKPACK MEDICAL OXYGEN SYSTEM
- K071585 — P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
- K071599 — EASYGUIDE
- K071630 — TERUMO 31G THINPRO INSULIN SYRINGE
- K071725 — M2 MONITOR
- K062331 — HIGHPAK-12
- K063154 — FACIAL RECONSTRUCTIVE MESH (FRM)
- K063357 — MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
- K063772 — EXPEDIUM SPINE SYSTEM
- K070293 — BENVENUE VCF OSTEO COIL SYSTEM
- K070333 — ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
- K070794 — ATLANTIK
- K071171 — VPAP AUTO WITH H3I
- K071629 — PARIETEX POLYESTER MESH WITH INTRODUCER
- K070732 — BCI AUTOCON 3304 DIGITAL PULSE OXIMETER
- K071264 — SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
- K071395 — BIOMET VISION FOOTRING SYSTEM
- K071452 — FL BOND II
Data sourced from openFDA. This site is unofficial and independent of the FDA.