FDA 510(k) clearances — page 371
clearances on record, most recent first.
Clearances — page 371
37,001–37,100 of 175,770- K134025 — AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT
- K140013 — SOPIX INSIDE, SOPIX2 INSIDE
- K140280 — FORTICORE
- K140528 — TRUE BEAM, TRUE BEAM STX, EDGE
- K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
- K141248 — SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
- K141343 — AXXENT CERVICAL APPLICATOR
- K141552 — ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
- K141562 — MSN-006
- K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K141574 — ARTIS ZEE/ZEEGO SW VC21
- K141824 — MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP
- K142035 — GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM
- K142105 — ELI 380 ELECTROCARDIOGRAPH
- K142127 — ELECSYS ESTRADIOL III CALCHECK 5
- K142157 — PALACOS R+G PRO
- K133797 — QMASTER-H/REVO
- K133889 — PREMIUM
- K134003 — RHINIX NASAL FILTER
- K140710 — BIOMET GRAFT DELIVERY SYRINGES
- K140947 — COMPAT ENTERAL DELIVERY PUMP SETS
- K140964 — CALCULASE II
- K141272 — FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR
- K141673 — IVAS 8 GAUGE BONE BIOPSY KIT
- K141719 — BIOGEL PL MICRO SURGICAL GLOVE
- K141831 — HYDRAVIEW GUIDEWIRE
- K141950 — HFD100 ROCKER ARM ACCESSORY
- K133851 — ALERE PBP2A SA/CONS CULTURE COLONY TEST
- K133911 — GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
- K134011 — GENERAL SPINAL SYSTEM
- K140418 — POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
- K140786 — XENCO MEDICAL CERVICAL INTERBODY SYSTEM
- K140804 — VDRIVE WITH V-LOOP/ VDRIVE DUO
- K140865 — INFRARED HEATING DEVICE
- K140877 — VERICORE ZIRCONIA BLANKS
- K141144 — STA LIATEST D-DI
- K141293 — PHOT-X IIS MODEL 505
- K141355 — VOLUMETRIC INCENTIVE SPIROMETER
- K141495 — TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
- K141514 — SYNAPSE 3D TENSOR ANALYSIS
- K141546 — VITALOGRAPH MODEL 7000 SPIROTRAC
- K141590 — EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
- K141635 — ARTHREX IBALANCE TKA SYSTEM
- K141840 — TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH
- K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
- K140874 — GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
- K141078 — ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
- K141370 — RENOVIS CEMENTED HIP SYSTEM
- K132631 — EIA SMDP IMMUNOASSAY
- K132855 — HEARTWAY POWER MOBILITY SCOOTER
- K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
- K133741 — ACCU-CHEK Performa Blood Glucose Monitoring System
- K140009 — SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
- K140342 — QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
- K140490 — CIVA SHEET PD-103
- K140735 — EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
- K141364 — CLIMB MAMMOGRAPHY VIEWER SOFTWARE
- K141440 — DICOMPACS DX-R WITH FLAT PANEL
- K141796 — DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
- K141848 — IOGYN SYSTEM
- K142097 — SELEC-3 I.V.ADMINISTRATION SET
- K142221 — MEMO 3D ReChord
- K140168 — EASYSTIM TN28_OTC
- K140204 — JWX-2
- K140582 — FINGERTIP PULSE OXIMETER
- K140892 — DISTAL ELBOW PLATING SYSTEM
- K141443 — INFRONT LUMBAR INTERBODY FUSION SYSTEM
- K141573 — SILVERLON ISLAND WOUND DRESSING
- K141821 — ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET
- K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
- K142086 — NIO -INTRAOSSEOUS DEVICE
- K142120 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
- K142135 — REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
- K142166 — TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES
- K132380 — PREVANTICS DEVICE SWAB
- K133023 — JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
- K133549 — STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
- K133724 — MINNCARE HD
- K140338 — CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)
- K140850 — GENESIS REUSABLE RIGID CONTAINER SYSTEM
- K140862 — MONICA NOVII WIRELESS PATCH SYSTEM
- K141162 — ALL-CERAMIC ZIRCONIA BLOCK
- K141230 — DOSELAB PRO
- K141239 — LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
- K141305 — RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K141307 — AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K141318 — CIANNA MEDICAL SGS SYSTEM
- K141435 — OPAL CHIRO, 20/20 P-DR
- K141762 — PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
- K133334 — VERITRACT ENTERAL FEEDING TUBE SYSTEM
- K133667 — SLIT LAMP SL-D701
- K133678 — CONFIRM BIOACTIVE
- K133979 — TENS
- K140305 — CAYA CONTOURED DIAPHRAGM
- K140458 — DIOTECH LASER FIBER
- K141021 — POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
- K141095 — STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
- K141291 — VERTIFORM POSTERIOR FIXATION SYSTEM
- K141451 — VixWin Platinum
- K141497 — PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
Data sourced from openFDA. This site is unofficial and independent of the FDA.