FDA 510(k) clearances — page 640
clearances on record, most recent first.
Clearances — page 640
63,901–64,000 of 175,825- K053007 — SKYLARK URO PROBE
- K053133 — SYNGO DYNAMICS, VERSION 5.0
- K053192 — MODEL 418 SERIES WALKERS
- K051736 — FOX PULSE OXIMETER
- K052348 — IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
- K052748 — SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS
- K053105 — SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP
- K053152 — BIOHORIZONS SINGLE-STAGE IMPLANT
- K051858 — ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
- K051964 — POWERNEB
- K052184 — GIVEN DIAGNOSTIC SYSTEM
- K052388 — SERIM PERACETIC ACID CHEMICAL INDICATOR
- K052395 — STERILE EQUIPMENT COVERS
- K053080 — GRAFTCAGE ACX
- K053186 — VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
- K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
- K042707 — GRAFTON PLUS DBM PASTE
- K051280 — MEDCOMP SPLIT CATH II
- K051401 — ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
- K052339 — ASAHI PTCA GUIDE WIRE
- K052477 — DAMON 3 MODIFIED
- K052610 — IMAGE STAR II
- K052662 — ONE STEP FSH MENOPAUSAL TEST
- K052675 — SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS
- K052814 — LUMINA 1600, 3300 AND 6600 SYSTEMS
- K052892 — SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
- K052980 — LIBERTY GLUCOSE CONTROL, MODEL 2120031
- K053082 — BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
- K053083 — DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
- K053126 — BINAXNOW INFLUENZA A & B TEST
- K053128 — SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
- K051925 — CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
- K052387 — ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
- K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
- K052432 — MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2
- K052401 — GYNECARE TVT SECUR SYSTEM
- K052481 — BD VIPER SYSTEM
- K052568 — ESTEEM STRETCHY VINYL GLOVE WITH COATING
- K052900 — QUILL NONABSORBABLE NYLON BARBED SUTURE
- K053059 — ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
- K053098 — OPTIUM DBM GEL AND PUTTY
- K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
- K051821 — INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
- K052578 — BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
- K052667 — ARTSANA PISTON AND INSULIN SYRINGES
- K043048 — GRAFTON PLUS DBM PASTE
- K050209 — SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
- K050800 — NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
- K051102 — OMNIPICC PI
- K051299 — IGD DIAGNOSTIC TEST KITS
- K051455 — WIESLAB CAP MPO-ANCA
- K051672 — POWERPICC
- K051734 — GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
- K051963 — BE-CERTAIN PREGNANCY TEST
- K052218 — CRONO FIVE AND CRONO PCA 50
- K052255 — ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
- K052257 — VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
- K052264 — QUANTA LITE CCP3 IGG ELISA
- K052304 — SUPER PORCELAIN EX-3 PRESS
- K052335 — ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
- K052391 — VISION (WITH OFF-LINE REVIEW)
- K052455 — IMPRESSIX
- K052561 — TERUMO MICRO TAPERED PEN NEEDLE
- K052745 — ASSISTO ARM SYSTEMS
- K052834 — MREYE EMBOLIZATION COIL
- K052872 — IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A
- K052894 — SONOLINE G60 S ULTRASOUND SYSTEM
- K053054 — THROMBIX 3X3 HEMOSTATIC PAD
- K053155 — VIMPLANT
- K051034 — URYXXON 200 URINE ANALYZER
- K051161 — QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
- K051458 — WIESLAB CAP PR-3 ANCA
- K052059 — IUI CATHETER, MODEL 9057
- K052092 — RPS ADENO DETECTOR
- K052196 — VILEX X-FIX
- K052374 — RAPID PROGEAMMER 3.0
- K052524 — BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
- K052612 — DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR
- K052784 — DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
- K052874 — SOPRANO HAIR REMOVAL DIODE LASER
- K052879 — NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
- K052977 — DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
- K053002 — DEPUY CMW 1 GENTAMICIN BONE CEMENT
- K053003 — DEPUY CMW 1, 2 AND 3 BONE CEMENTS
- K053010 — VISTADENT AT COMPLETE, MODEL 3.1
- K053027 — VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
- K053038 — HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
- K051836 — SKELITE RESORBABLE CEMENT RESTRICTOR
- K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
- K052381 — GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
- K052702 — MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY
- K052837 — SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
- K053000 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
- K053045 — MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K050398 — EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
- K051144 — ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
- K051149 — MEDITECH MODEL ABPM-04
- K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
- K051330 — UVBIOTEK MODELS 3200B AND 4000B
- K051578 — IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
Data sourced from openFDA. This site is unofficial and independent of the FDA.