FDA 510(k) clearances — page 1029
clearances on record, most recent first.
Clearances — page 1029
102,801–102,900 of 175,890- K951979 — SUNGLASSES
- K952131 — SAS FEBRILE ANTIGEN SET
- K952135 — SAS SALMONELLA H D ANTIGEN
- K952136 — SAS SALMONELLA H B ANTIGEN
- K952137 — SAS SALMONELLA H A ANTIGEN
- K952138 — SAS FRANCISELLA TULARENSIS ANTIGEN
- K952140 — SAS BRUCELLA MELTIENSIS ANTIGEN
- K952142 — SAS SALMONELLA O GROUP D ANTIGEN
- K952147 — SAS BRUCELLA ABORTUS ANTIGEN
- K952191 — FORGED CEMENTED STEM
- K952199 — ACTIVE INTACT PTH ELISA
- K952250 — STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT
- K952281 — ACTIVE FREE TESTOSTERONE RIA
- K952283 — AMERLITE HCG-60 ASSAY
- K952297 — FOUNDATION TEXTURED STEM
- K952299 — SURGISCAN SCANNER
- K952350 — JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
- K952463 — GS & GS20 SURGICAL TOOL SYSTEM
- K952587 — ENDOCARE MONOPOLAR ELECTRODES
- K952593 — N/T PROTEIN CONTROL SY/L, M AND H
- K952594 — N PROTEIN STANDARD SY
- K952772 — MEGABEAM ENDO-ENT PROBE
- K952977 — SABRE MULTI-USE TROCAR SYSTEM
- K926253 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE
- K934435 — CAP-STIK
- K934775 — STC COCAINE METABOLITE EIA
- K935564 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION
- K935565 — OPIATES MICRO-PLATE ASSAY
- K935573 — AMPHETAMINES MICRO-PLATE EIA
- K935588 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION
- K942543 — ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
- K942988 — FILTERED EXTENSION SETS
- K944956 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
- K944957 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
- K944966 — UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
- K945296 — CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160
- K945592 — VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE
- K945706 — BONE DRILL
- K945937 — TE-800 PELVIC FLOOR EXERCISER
- K950154 — 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES
- K951507 — PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE
- K951537 — GLUCOMETER ELITE M BLOOD GLUCOSE METER
- K951605 — SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
- K951606 — KIS-II IMPLANT FIXTURES
- K951724 — QUANTITATIVE EEG ANALYSIS SOFTWARE
- K951843 — REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
- K951924 — ORGANIC TAMPONS
- K951941 — CITATION MULTIPLE USE DELTA SCOPE
- K952211 — AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)
- K952289 — WELCH ALLYN FIBER OPTIC HEADLIGNT
- K952334 — DRESSING CHANGE TRAY
- K952516 — PRO-VENT, LINE DRAW, PULSATOR
- K952539 — RADIOLOGY PACKS
- K952561 — WATER JEL BURN KIT
- K952663 — 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP
- K952854 — PULPDENT GLASS IONOMER CEMENTS
- K936305 — SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
- K940631 — CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
- K942087 — BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
- K944507 — METALLIC RADIAL HEAD IMPLANTS
- K945099 — PARAMETERS MONITORES
- K946362 — SILON SILICONE FOAM SHEETING
- K950075 — MED-TEC TRAY ADAPTER
- K950085 — MULTICURE(R) S GEL PAD
- K951809 — GLIDING NAIL
- K951844 — BIOMECHANIC LOW-PROFILE CABLE SYSTEM
- K951888 — DADE STRATUS TROPONIN-I CONTROL
- K951890 — STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
- K952534 — TENTATIVELY POLARUS EX ROD
- K952672 — VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM
- K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER
- K952823 — FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
- K952891 — CRONEX LOW ABSORPTION CASSETTE
- K915766 — MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
- K915767 — MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS
- K940039 — PELLETHANE 75D
- K942271 — LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE
- K942647 — COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI
- K943057 — CAP SAFE SYSTEM
- K943616 — BELTONE PERSONAL HEARING SCREENER
- K943855 — BONE FIXATION NAIL
- K945321 — WELLHOFER WP700 V. 3.2
- K950595 — LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
- K950962 — KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
- K951679 — MED-TEC TESTICULAR SEPARATOR
- K951862 — A GEL WOUND DRESSING
- K951925 — DICOMIT
- K951947 — MED-TEC RADIO THERAPY TREATMENT CHAIR
- K952420 — STERIGAUZE WET DRESSING
- K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
- K952890 — SUNGLASSES
- K952925 — READY NURSE SYSTEM (RNS) TRACH CARE KIT
- K953002 — METAL FRAM WITH POLYCARBONATE LENS
- K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
- K953030 — SLIT LAMP AIA 11
- K932453 — VISUWELL SYPHILIS ANTIBODY
- K934628 — CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS
- K935263 — FOUNDATION POROUS STEM
- K942263 — MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
- K942432 — J.B.S. CERVICAL SPINE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.