FDA 510(k) clearances — page 507
clearances on record, most recent first.
Clearances — page 507
50,601–50,700 of 176,542- 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
- K101460 — LOCI 8 CALIBRATOR, MODEL KC 646
- K101514 — BD DIRECTIGEN EZ RSV
- K101629 — FIL 1520
- K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
- K101680 — WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
- K093801 — IMPELLA CONTROLLER
- K100057 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K100234 — HM-LAMP II
- K100253 — VISUMAX LASER KERATOME
- K100461 — PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
- K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
- K101032 — CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX
- K101060 — SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
- K101144 — MODIFICATION TO:RADIUS SPINAL SYSTEM
- K101415 — THERACLEAR
- K101648 — HI-TORQUE WINN GUIDE WIRE FAMILY
- K100984 — XYLOS VESSEL GUARD
- K091409 — LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
- K093383 — NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
- K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
- K100287 — JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
- K100728 — ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
- K101195 — 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
- K101736 — NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
- K090950 — BONE PLUS BCP
- K092859 — MERITS MODEL N SERIES NEBULIZER COMPRESSORS
- K093189 — ACTIPROTECT UC N95 RESPIRATOR
- K093473 — KMD-MARK1 TISSUE MARKER
Data sourced from openFDA. This site is unofficial and independent of the FDA.