FDA 510(k) clearances — page 985
clearances on record, most recent first.
Clearances — page 985
98,401–98,500 of 175,890- K961662 — ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
- K961759 — CEMENT AND BONE REMOVAL KIT
- K961810 — SUPPLE PERI-GUARD PERICARDIUM
- K961811 — PERI-GUARD PERICARDIUM
- K961812 — ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES
- K935024 — ESI-5000
- K953680 — FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
- K960546 — CLINITEK 50 URINE CHEMISTRY ANALYZER
- K961212 — SPINAL TOUCH
- K961325 — ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP
- K961393 — TRICYCLICS SERUM TOX ASSAY
- K961409 — PORTA'PURE/DENTAL
- K961458 — AVL 9180 ELECTROLYTE ANALYZER
- K961487 — ELECSYS HCG ASSAY
- K961488 — ELECSYS T-UPTAKE ASSAY
- K961515 — QUANTASE PHENYLALANINE ASSAY
- K955104 — HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
- K961040 — BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC
- K961070 — ESOPHAGEAL MANOMETRY ANALYSIS MODULE
- K961160 — UPACS VERSION 1.7
- K961301 — E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
- K961489 — ELECSYS FT4 ASSAY
- K961500 — ELECSYS TROPONIN T
- K961501 — ELECSYS CK-MB
- K961822 — WET-PREP
- K961828 — LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
- K961945 — TYMPANOSTOMY VENTILATION TUBE
- K962004 — AQ HYDROPHILIC UROLOGICAL CATHETERS
- K936135 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
- K952513 — LESE STENTS SETS
- K955389 — MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
- K955424 — OSTAR
- K955529 — CRYTRON SYSTEM
- K955634 — MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
- K955947 — OSTAR EXAMINATION GLOVES
- K961026 — BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
- K961227 — JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
- K961309 — POS-T-VAC ID-300
- K961574 — TONGUE SCRAPPER
- K961714 — ASEPTYLUM, UNI-CARRIER
- K961879 — ELECTRONIC THERMOMETER
- K951709 — MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
- K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
- K952054 — SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
- K953690 — CLS STEM (MODIFICATION)
- K954774 — SHIELDED TROCAR (OBTURATOR)
- K955059 — OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER
- K955132 — HEARTPORT ENDOAORTIC CLAMP
- K955345 — LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
- K960025 — PROTEK LOW PROFILE ACETABULAR CUP
- K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
- K960981 — KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
- K961173 — 1.2MM REUSABLE NEUROVIEW ENDOSCOPE
- K961300 — ASPIRATION/IRRIGATION CATHETER
- K961395 — MEDI-TRACE RADIOLUCENT
- K961623 — FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
- K954131 — HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND
- K960036 — FIRARD II/ TDP LAMP
- K960704 — DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
- K961051 — UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)
- K961056 — BIOVIEW MODEL S960000
- K961061 — CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
- K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMER
- K961527 — MX703 AND MX730 CONTINUOUS FLUSH DEVICES
- K961990 — NON-PRESCRIPTION SUNGLASSES
- K942525 — MEDICOUNT DEKA HEMATOLOGY ANALYZER
- K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
- K950829 — MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
- K954063 — GLOVE SEAL & SET-RITE
- K954513 — ACE SREW DENTLA IMPLANT SYSTEM
- K954605 — ACE CYLINDER DENTAL IMPLANT
- K955181 — U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
- K955776 — ACU-LAB
- K960045 — ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
- K960438 — TINTELIZE PAI-1 KIT
- K960614 — SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
- K960676 — ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
- K960900 — IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW
- K960937 — SUCTION SAFETY DEVICE
- K961020 — STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS
- K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL
- K961189 — TAS A PTT TEST CONTROLS
- K953681 — HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
- K954798 — 7100 SWALLOWING WORKSTATION
- K955182 — NIPRO ARTERIAL VENOUS FISTULA NEEDLE
- K960916 — SAMS 8000 CARDIOPLEGIA MONITOR
- K960924 — KOWA HAND-HELD APPLANATION TONOMETER HA-1
- K960957 — EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
- K960987 — LIQUICHEK RHEUMATOID FACTOR CONTROL
- K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES
- K955258 — 3030 INFUSION PUMP
- K955687 — RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
- K960086 — DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
- K960892 — THE COBALT SCALPEL
- K960905 — SDL DIODE LASER SYSTEM
- K960941 — UPACS
- K961097 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
- K961136 — PULSEMASTER
- K961351 — HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
- K961431 — LACTATE DEHYDROGENASE REAGENT SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.