FDA 510(k) clearances — page 985
clearances on record, most recent first.
Clearances — page 985
98,401–98,500 of 176,637- K962344 — MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K962508 — ELECSYS T3
- K962594 — ACA PLUS FT4 CALIBRATOR
- K962602 — ACA PLUS FREE THYROXINE(FT4) METHOD
- K962650 — PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)
- K962669 — ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
- K962673 — ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
- K962841 — OPUS MYOGLOBIN CONTROLS
- K962997 — NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
- K955719 — SICKLE-2000
- K955931 — MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
- K960474 — COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
- K960656 — GORE BURR HOLE COVER
- K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
- K961893 — DURAFLOR
- K961894 — MDI TUTOR
- K961914 — BACTERIA/VIRAL FILTER
- K962048 — 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
- K962152 — OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
- K962162 — DALL-MILES TROCHANTER CABLE SUPERGRIP
- K962287 — EAGLE EYES SUNGLASSES
- K962461 — NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES
- K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY
- K962670 — NHMC IRRIGATION TRAY
- K962678 — BIPOLAR PENCIL COAGULATOR
- K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
- K952614 — JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
- K953946 — MICROSELECTRON-HDR VERSION 2
- K954205 — THE AMPLATZ THROMBECTOMY DEVICE
- K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
- K961867 — PEEP VALVE
- K961927 — RMI HEMOCONCENTRACTOR TUBING SET
- K961939 — S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
- K961983 — TRS 2000 TELERADIOLOGY SYSTEM
- K962082 — OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
- K962476 — UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
- K952050 — GLOVE, EXAMINATION, VINYL
- K952163 — DAVID BACK CLINIC SYSTEM
- K954789 — BRAINLAB HEADPINS
- K955742 — D. DEVICE II
- K960445 — INPUT TUOHY-BORST LOCKING DEVICE
- K960686 — HYCOAT
- K960749 — HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
- K960843 — STOP-N-GROW
- K961869 — DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
- K962005 — EXTRAHAND BALLOON RETRACTOR
- K962785 — 3M DENT SYSTEM
- K955563 — FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
- K955713 — NOBELPHARMA BONE ANCHORED HEARING AID
- K961139 — EAGLE PATIENT MONITOR MODEL 3000/3100
- K961467 — HEAD RETAINING DEVICE
- K961791 — DEPUY DISPOSABLE FILTER/HOOD
- K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212
- K961855 — POLAR CARE (MODEL 500/50000)
- K961872 — INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
- K961922 — RDP-2
- K962119 — RE-NEW LAPAROSCOPIC INSTRUMENTS
- K962238 — SELECT SHOULDER KEELED ALL-POLY GLENOIDS
- K962244 — SELECT SHOULDER PEGGED ALL-POLY GLENOID
- K962328 — SINGLE USE INSTRUMENT TRAY
- K962380 — OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
- K962530 — PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
- K962533 — OLYPUS FG SERIES GRASPING FORCEPS
- K962600 — REXAM SELF-SEAL TYVEK POUCH
- K962693 — MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
- K962847 — MT10P, MT60-PP, MT60-AGC0, AND MT60
- K954028 — HP SONOS ULTRASOUND IMAGING SYSTEM
- K954769 — BIEGLER BW385L BLOOD & INFUSION WARMER
- K954987 — ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
- K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
- K955270 — TAPE & BANDAGE, ADHESIVE
- K955525 — FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
- K955916 — TOWNLEY TOTAL ELBOW SYSTEM
- K960625 — SPREADABLE SHEATH INTRODUCER SET
- K960765 — MENTOR ADVENT A/B SYSTEM
- K960908 — SRRS PRESSED FIT FEMORAL REVISION COMPONENT
- K961116 — FIRST BEAT/CARDIO BEAT/CALC
- K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
- K961288 — BODYTRODE
- K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
- K961902 — SIEMENS BEAM SHAPER
- K961998 — QUALITROL SYPHSERO CONTROL SET
- K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
- K962132 — SILKON STAINLESS STEEL CABLE SYSTEM
- K962210 — BACTEC 9050 SYSTEM
- K962346 — PAPILLOTOME
- K962362 — CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS
- K955766 — ADULT-PEDIATRIC TRANSPORT SYSTEM
- K960422 — PRUITT SAFETY OCCLUSION CATHETER
- K960544 — CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
- K960761 — PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
- K960976 — KINEMATIC II REPLACEMENT TIBIAL INSERTS
- K961413 — SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
- K961472 — DENTAL DAM SILICONE
- K961858 — COSGROVE DEPTH ELECTRODE KIT(CDEK)
- K961877 — PISTON SYRINGE
- K961918 — MULTI-TEST II
- K962086 — CPS, CEMENTED CUP SYSTEM
- K962333 — V.R.S. DENTURE RESIN MATERIAL
- K962606 — TOPOGRAPHIC IMAGING MARKER
Data sourced from openFDA. This site is unofficial and independent of the FDA.