FDA 510(k) clearances — page 1300
clearances on record, most recent first.
Clearances — page 1300
129,901–130,000 of 175,890- K893159 — GLOBE PATIENT EXAMINATION GLOVES
- K893279 — LATEX EXAMINATION GLOVES
- K893280 — PROFECT EXAMINATION GLOVES
- K893294 — POWDER FREE VINYL (PVC) EXAM GLOVES
- K893833 — AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER
- K893872 — P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
- K893932 — LATEX EXAMINATION GLOVES
- K893968 — VKG 2000 VIDEO KERATOMETER
- K894025 — VINYL EXAMINATION GLOVES (NON-STERILE)
- K894124 — OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
- K894398 — STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE
- K894399 — STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.
- K894427 — DISPOSABLE IV INDUCTION COVER
- K894770 — PERSONAL BACK WITH FIP KIT
- K894927 — SURGI SQUEEZ
- K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
- K895015 — ARTROMOT(TM) CPM DEVICES
- K895016 — MODEL #510/515 GENERAL TRANSPORT STRETCHER
- K895107 — ACE ORTHOPAEDIC WASHERS
- K895121 — INTERMEDICS POWER BROACH IMPACTOR
- K895165 — ZIGGY MEDICHAIR
- K875317 — ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID
- K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
- K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
- K885168 — RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
- K892108 — STERILE NATURAL LATEX SURGICAL GLOVES
- K892191 — PATIENT EXAMINATION GLOVES (VINYL)
- K893050 — PATIENT EXAMINATION GLOVES
- K893263 — LATEX EXAMINATION GLOVES
- K893553 — BIPOLAR ELECTROSURGICAL SNARE
- K893721 — LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
- K893722 — LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
- K893723 — LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
- K893836 — EPLAB (ELECTROCARDIOGRAPHIC MONITOR)
- K893965 — PROLONG INTRAVASCULAR CATHETER
- K893992 — NOETIX, BIOPSY NEEDLE
- K894049 — IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT
- K894419 — GASTRO ENTEROLOGICAL BIOPTOME
- K894592 — LAMANO DIRECTORS
- K894612 — INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM
- K894690 — CPAP MASK
- K894788 — DMI SERIES 90 EXAMINATION TABLE
- K894829 — CEFIXIME 5 MCG SENSITIVITY DISKS
- K894845 — (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
- K884970 — PINSET
- K890087 — ACUDATA INDICATENS MODEL 5M
- K892622 — PATIENT EXAMINATION GLOVES (LATEX)
- K893390 — MODIFIED PRISTINE CULTURE CATHETER
- K893811 — SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
- K894059 — ISOLIGHT
- K894060 — ESSE QUATTRO/ESSE UNO
- K894063 — TRIGLYCERIDE (GPO) TRINDER REAGENT
- K894170 — DEVON DISPOSABLE HEAD POSITIONER COVER
- K894218 — NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
- K894265 — DSL 17A-OH PROGERSTERONE (DSL #6800)
- K894290 — ACCESS TM
- K894482 — LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
- K894483 — GLUCOSE-HK TEST (GLU-HK) ITEM #65415
- K894542 — ELSCINT'S EXEL 2400E CT SCANNER
- K894683 — FABFOAM #302
- K894783 — PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
- K894838 — HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
- K890913 — SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT
- K891118 — STERLING TENS
- K891622 — STERILE SURGICAL NATURAL LATEX GLOVES
- K891676 — ARVEE APNEA MONITOR, MODEL 2400
- K892176 — CORRECT TOUCH SURGEONS GLOVES
- K893899 — STERILE LATEX SURGICAL GLOVES
- K894127 — LUMISCOPE MODEL 1000/APCC MODEL 1000
- K894431 — MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
- K894848 — HAEMOPHILUS TEST MEDIUM (BROTH)
- K885133 — APACERAM ARTIFICIAL DENTAL IMPLANT
- K890687 — ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER
- K891265 — LATEXCO LATEX EXAMINATION GLOVES
- K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE
- K892080 — PATIENT EXAMINATION GLOVES (LATEX)
- K892081 — PATIENT EXAMINATION GLOVES (LATEX)
- K892994 — NON-STERILE VINYL EXAMINATION GLOVES
- K893049 — LANDSCAPE PATIENT EXAMINATION GLOVES
- K893216 — RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
- K893411 — STEALTH DILATION CATHETER SYSTEM
- K893418 — MYOCARDIAL PROBE THERMOMETER CODE 64000
- K893474 — BARD CATH LAB THERMODILUTION CATHETER
- K893587 — OXIMETER
- K893778 — CALCIUM TEST ITEM NUMBER: 65409
- K893963 — VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
- K894003 — PATIENT EXAMINATION GLOVES
- K894101 — ROCHE REAGENT FOR URIC ACID
- K894145 — EMIT T-UPTAKE ASSAY
- K894146 — GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
- K894148 — MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
- K894173 — BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
- K894317 — HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
- K894329 — RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
- K894359 — CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
- K894408 — ABBOTT TESTPACK PLUS HCG URINE
- K894466 — HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
- K894467 — THROMBIN TIME REAGENT
- K894503 — GEMTAB SYSTEM
- K894562 — ARBO H79P DISPOSABLE MONITORING ELECTRODES
Data sourced from openFDA. This site is unofficial and independent of the FDA.