FDA 510(k) clearances — page 1048
clearances on record, most recent first.
Clearances — page 1048
104,701–104,800 of 176,637- K931490 — SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY
- K932031 — AMBU PORTABLE SUCTION UNIT
- K932742 — EBNA IGG ELISA TEST SYSTEM
- K935755 — THE ULTRA
- K941608 — INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING
- K942504 — INSTASPOT
- K942725 — CMI VELVET TOUCH VACUUM EXTRACTOR
- K942820 — H292
- K944265 — NEEDLE ELCTRODE
- K944330 — ACUTRAK PLUS FIXATION SYSTEM
- K944736 — VSP (VARIABLE SCREW PLACEMENT)
- K945318 — TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA
- K945367 — CIBA CORNING ACS CORTISOL IMMUNOASSAY
- K945685 — KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
- K946057 — AQUALARM MOISTURE SENSOR MODEL P85000
- K950013 — CONSENSUS(TM) ORTHOPEDIC DRILL BIT
- K950056 — THE GRIESHABER AXIAL CUTTER
- K950346 — B-L RED(TM) DISCS
- K950432 — VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER
- K950457 — CANNUAL AND TROCAR, SUPERPUBIC
- K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
- K950893 — KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS
- K951122 — CAPITOL URINE DRUG SCREEN COLLECTION KIT
- K951302 — SMALL FRAGMENT PLATES AND SCREWS
- K951361 — DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
- K951392 — MINIBONEPLATE SYSTEM
- K951425 — SPECTRUM CURING LIGHT POLYMERIZATION UNIT
- K921791 — WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
- K922688 — EXTRA PROTECTION POLYURETHANE CONDOM
- K930618 — VAGINAL CONTINENCE DEVICE
- K933417 — ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER
- K933654 — BLADDER NECK SUPPORT PROTHESIS FITTING KIT
- K940013 — BODY POSITION INDICATOR, MODEL BPI1
- K940910 — FILTRYZER
- K943156 — SYSTEM, IMAGE PROCESSING
- K944004 — VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)
- K944833 — DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
- K945319 — TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT
- K946378 — BCM 400CP
- K950431 — LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
- K950502 — CCD ENDOCAM 5501
- K951005 — KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
- K951146 — IMAGING TABLE
- K951372 — PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
- K951503 — CVD BULLETT HI-FLO INFUSION CATHETER
- K951744 — LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
- K925469 — JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
- K925581 — BAXTER BIOSTAT 1000 UREA MONITOR
- K936009 — AMS 3000M
- K940951 — RW RESUCITAIRE INFANT RADIANT WARMER
- K941126 — QCT-BONE MINERAL ANALYSIS PHANTOM
- K941802 — OR TOWEL
- K941815 — ISOTRON III
- K942593 — OXYCHEK OXYGEN ANALYZER
- K943123 — PACETRAK
- K943124 — HEARTRAK
- K943938 — MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
- K944978 — BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
- K945185 — CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
- K945191 — ENDOSCOPIC ACCESSORY
- K945845 — MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT
- K946156 — DEPUY COMPRESSION HIP SCREW SYSTEM
- K950210 — CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
- K950387 — GEMINI
- K950446 — BONE CUTTING INSTRUMENT AND ACCESSORIES
- K950699 — PREVIEW TELEIMAGING SYSTEM
- K950784 — DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
- K950788 — OTOSCOPE A-34
- K950830 — STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP
- K950992 — CERAMAFLEX BRACKET SYSTEM
- K951296 — DELTON F PIT & FISSURE SEALANT
- K951312 — MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
- K951398 — MIST REDUCER SLEEVES
- K951445 — OLYMPUS FD-5 HOT BIOPSY FORCEPS
- K951480 — MIST TROCARS
- K951481 — MIST ENDOSCOPIC CANNULAS
- K951527 — THE PILOT AUDIOMETER
- K951589 — MANUAL SURGICAL INSRUMENT
- K951692 — MIST ENDOSCOPIC PROBES
- K912521 — DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH
- K934066 — NEPHRETECT
- K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
- K940483 — 2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE
- K940811 — BRAINTRACE
- K942784 — NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED
- K943978 — WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS
- K944692 — C-SERIES HOMEPUMP
- K945115 — MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
- K945508 — FX-2P NMS (2 CHANNEL PORTABLE)
- K945509 — FX-2 NMS (2CHANNEL TABLE MODEL)
- K945510 — FX-4 NMS (4CHANNEL TABLE MODEL)
- K946192 — HICHEM Y-GT REAGENT KIT
- K946250 — STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
- K946364 — E TEST FOR OFLOXACIN
- K950280 — TDX(R)/TDXFLX(R) FREE PHENYTOIN II
- K950292 — FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
- K950388 — POLARIS
- K950445 — VISUALINE II CANNABINOIDS (THC)
- K950520 — BURR, CORNEAL, BATTERY-POWERED
- K950761 — INDEX ACETABULAT COMPONENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.