FDA 510(k) clearances — page 730
clearances on record, most recent first.
Clearances — page 730
72,901–73,000 of 175,825- K022198 — ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
- K022212 — PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
- K022465 — MODIFICATION TO NASAL-AIRE
- K022873 — POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)
- K023078 — BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR
- K024132 — CHROMOPHARE X 65
- K024260 — CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
- K024282 — ACRYLIC
- K024287 — FIXOBRIDGE 3-CEMENT
- K024329 — JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
- K030032 — CROSSEAL APPLICATION DEVICE
- K030107 — 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
- K030114 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K030168 — AGC CEM
- K030331 — ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
- K030333 — LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
- K030397 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
- K030560 — POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE
- K030575 — MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
- K030579 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML
- K030590 — CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
- K030610 — POD PAC-20M
- K030615 — INFINITY EXPLORER
- K030657 — SIEMENS INFINITY GATEWAY SUITE, MODEL VF2
- K030731 — M2376A DEVICELINK SYSTEM
- K030768 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
- K030853 — STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI
- K022947 — ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
- K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
- K023189 — VISTA BASIC WITH FM SYSTEM
- K023192 — STRYKER BIOZIP SUTURE ANCHOR
- K023487 — HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
- K023692 — GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
- K024009 — CRYOPROBE
- K024012 — OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
- K024291 — ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
- K030117 — ENHANCE SPERM FREEZE
- K030149 — MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
- K030200 — POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
- K030269 — GENICON CLIP APPLIER
- K030368 — KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
- K030378 — STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
- K030411 — PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
- K030500 — ORIA ZENITH
- K030501 — X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
- K030537 — DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
- K030597 — SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
- K030647 — EVA DIGITAL DENTAL X-RAY SYSTEM
- K030698 — AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
- K030706 — EBI DYNAFIX COMPRESSION BONE SCREW
- K030814 — INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
- K023090 — OPTION-VF URINARY CATHETER, FV14218
- K023990 — CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
- K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
- K030287 — HEMOSIL FACTOR XI DEFICIENT PLASMA
- K030482 — WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
- K030552 — IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
- K030621 — ATAC CALIBRATOR
- K013936 — SILVERLEAF CONTACT WOUND DRESSING
- K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K022627 — DSG RELAXER SPLINT
- K023237 — XYLOS SURGICAL MESH
- K023472 — LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
- K023954 — ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
- K024251 — SIGHTFIX
- K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
- K030005 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
- K030096 — VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
- K030140 — DUOMED, SERIES 500, (MODELS ID 500, FL 500)
- K030626 — VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
- K023694 — BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
- K024160 — NEOSPORIN SCAR SOLUTION
- K024183 — ALTON PT STEPPER
- K024190 — FENESTRATED INFUSION CATHETER
- K024235 — DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
- K024357 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K024364 — SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
- K030161 — SUPERBOND
- K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE
- K030438 — BARD AQUAGUIDE URETERAL CONDUIT
- K030503 — MODIFICATION TO CONTOUR POLARIS URETERAL STENT
- K030609 — MODULEAF
- K030628 — SAS RSV CONTROL KIT
- K024124 — SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
- K024180 — ORAMAGICRX ORAL WOUND RINSE
- K024199 — IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
- K024275 — AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
- K030077 — GISH TUBING AND CONNECTORS WITH GBS COATING
- K030228 — POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
- K030464 — GEM, MODEL 004110
- K030467 — GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET
- K030475 — GDC STRETCH RESISTANT DETACHABLE COIL
- K030532 — CPCA2000 COUNTERPULSATION SYSTEM
- K030679 — MAS LIPID LEVEL 1 AND 2
- K022923 — CANDELA GENTLE YAG LASER SYSTEM
- K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
- K023111 — GYRUS PLASMA SKIN RESURFACING SYSTEM
- K024115 — MICROFIX QUICKANCHOR PLUS
- K030350 — EXPRESS MINI GLAUCOMA SHUNT
- K030455 — BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.