FDA 510(k) clearances — page 499
clearances on record, most recent first.
Clearances — page 499
49,801–49,900 of 175,770- K101255 — ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
- K101282 — SCOUTPRO HEMOSTATIC VALVE
- K101596 — KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
- K101674 — WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0
- K101778 — GIRAFFE INCUBATOR
- K101788 — GIRAFFE OMNIBED
- K101804 — GIRAFFE AND PANDA WARMERS
- K102008 — GLIDESHEATH
- K092329 — SOPIX 2
- K100702 — STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
- K100802 — AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
- K100805 — GALLERY LAMINOPLASTY FIXATION SYSTEM
- K100986 — CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
- K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
- K100765 — FIXPINE II SYSTEM
- K101095 — DIRECT PERORAL CHOLANGIOSCOPY BALLOON
- K101455 — EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
- K101625 — COHEN CROSSOVER CATHETER
- K092713 — SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
- K092813 — ASTRASONIC SPIROMETER, MODEL 29-8000
- K092860 — LASEMAR 800, 1000, 1500
- K093784 — ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
- K100439 — MEDIWORKS SLIT LAMP
- K100603 — RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
- K100611 — RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
- K100752 — PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
- K100964 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K101087 — REPROCESSED RESTEP COMPRESSION SLEEVES
- K101092 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
- K101102 — POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE
- K101103 — POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1
- K101108 — ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
- K101117 — LEV-OR DILATION CATHETER OTW
- K101146 — WATER BOTTLE CAP SYSTEM
- K101343 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K101720 — JULIET OL
- K101829 — THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
- K101840 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K101841 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K092819 — REMEL SPECTRA VRE
- K093024 — YEAST TRAFFIC LIGHT PNA FISH
- K093497 — THD BANDY
- K093775 — EVGUIDE TIP LOCATION SYSTEM
- K093903 — ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
- K100066 — DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
- K100109 — LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE
- K100441 — XINIWAVE, MODEL XW-18
- K100481 — SMITH & NEPHEW MDF MODULAR SLEEVE
- K100644 — OPTOS LIMITED PANORAMIC 200CAF
- K100762 — FLAT PANEL DETECTOR, MODEL FDR D-EVO
- K101109 — VIVATRAK
- K101140 — DENTLIGHT ORAL EXAM LIGHT KIT
- K101252 — NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
- K101254 — NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
- K101284 — FACET SCREW SYSTEM
- K101796 — PACSMATE MMD-5201M MONITOR
- K101851 — VENTRALIGHT ST MESH
- K093179 — MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
- K093648 — SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
- K100038 — DISPOSABLE REFLECTIVE MARKER SPHERES
- K100876 — AESCULAP MONOMAX ABSORBABLE SUTURE
- K101053 — OLYMPUS CF TYPE Y0023-L, Y0023I
- K101328 — ENSITE VELOCITY SYSTEM
- K101735 — ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
- K101858 — PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
- K093262 — AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM
- K100121 — MODEL 300157 CPAP SYSTEM
- K100360 — BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
- K100826 — PENUMBRA CATHERER 025
- K100890 — VARIAN HIGH ENERGY LINEAR ACCELERATOR
- K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
- K101047 — PTA-DUO PTA BALLOON CATHETER
- K101570 — HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
- K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
- K093910 — IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
- K093967 — VARIAN TREATMENT
- K100840 — EMBO PLUS EMBOLECTOMY CATHETER
- K100842 — PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
- K100925 — ASCENSION ANKLE FUSION NAIL SYSTEM
- K101059 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
- K101411 — SAVI PREPARATION DEVICE
- K092306 — SECURACATH UNIVERSAL
- K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM
- K092853 — 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
- K093964 — VENOFER PUMP
- K100405 — FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
- K100428 — MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
- K100432 — POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
- K100434 — CLAVE NEUTRON
- K100511 — COTEC DENTAL IMPLANT SYSTEM
- K100595 — ECLERIS MICROSTAR COLPOSCOPE
- K100600 — PROSTHODONTIC SCREWDRIVER , MODEL IA-400
- K100647 — A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
- K100658 — U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
- K100732 — FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
- K100740 — MD2000B VITAL SIGN MONITOR, MODEL MD2000B
- K100818 — ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
- K100907 — NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
- K100956 — SPONDY SPINAL FIXATION SYSTEM
- K101022 — PULMOTRACK 5050 WHOLTER, MODEL 5050
Data sourced from openFDA. This site is unofficial and independent of the FDA.