FDA 510(k) clearances — page 628
clearances on record, most recent first.
Clearances — page 628
62,701–62,800 of 176,637- K061683 — TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
- K061687 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
- K061713 — MAGIS1; MAGIS2
- K061743 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000; VACUUM TIGHT, MODEL BSQ-VHK 2001
- K061823 — ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
- K061946 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
- K061969 — PREFORMANCE POSTS AND TEMPORARY CYLINDERS
- K061977 — PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
- K053060 — TCS UNBREAKABLE
- K053417 — M-COR HIP REPLACEMENT SYSTEM
- K061056 — RANDOX LIQUID PROTEIN CALIBRATOR
- K061200 — PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
- K061202 — REVERE STABILIZATION SYSTEM
- K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
- K061439 — AEQUALIS REVERSED PROSTHESIS
- K061470 — DEL SOL BLUE LIGHT THERAPY SYSTEM
- K060233 — TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
- K061146 — SBI ULNAR HEAD IMPLANT
- K061275 — MEDLINE SYRINGES, MULTIPLE
- K061294 — KFX KNOTLESS FIXATION SYSTEM
- K061389 — ALLTHREAD LACTOSORB SUTURE ANCHOR
- K061704 — OPTILENE MESH
- K061711 — OASIS WOUND MATRIX
- K061767 — QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
- K061909 — HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
- K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K053236 — DAVID PREGNANCY TEST (MIDSTREAM)
- K053479 — VERIFY DRY HEAT LABEL
- K053547 — SMARTPILL GI MONITORING SYSTEM
- K060186 — POLYPLEX STIMULATING CATHETER SYSTEM
- K060751 — INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
- K060859 — COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
- K060897 — EMBEDDING TOOL, MODEL TE-1000
- K061124 — ORTHOPEDIC SOURCE PRESS-FIT HIP
- K061168 — PCA 36MM FEMORAL HEADS
- K061304 — CD HORIZON SPINAL SYSTEM
- K061307 — BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK
- K061510 — SANARUS VISICA TREATMENT SYSTEM
- K061536 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
- K061607 — STORM OPERATING KIT, MODEL 1-10-0
- K061765 — KALIX II IMPLANT
- K061778 — NUVASIVE SPHERX II SYSTEM
- K061792 — DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
- K061818 — DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
- K061939 — MODIFICATION TO ALLOMATRIX CUSTOM
- K052574 — COMPACT PLUS - EXTREME - PERFECT PLUS
- K053215 — SURGICAL MESH SYSTEM
- K053624 — MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
- K060675 — ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
- K060891 — VIRTUAL
- K061090 — GALILEO GOLD ASV
- K061243 — SMITH & NEPHEW MODULAR FEMORAL HEAD
- K061553 — NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
- K061748 — FRAGMENT PLATE SYSTEM
- K061833 — DEPUY AML HIP PROSTHESIS
- K053578 — SCORPION ULTRASONIC SCALING INSERTS
- K053646 — INVITRO MATURATION MEDIA
- K053656 — TYRX ANTIMICROBIAL MESH
- K060067 — MASKMEDIC CONCEPT NASAL MASK
- K060812 — POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
- K060952 — COLLAGEN NERVE WRAP
- K061037 — PDS PLUS ANTIBACTERIAL SUTURE
- K061050 — GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
- K061065 — FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
- K061066 — SYNERGY HIP SYSTEM
- K061349 — OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
- K061535 — GC XLC-100 CAPSULE
- K061641 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
- K061710 — CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS
- K060384 — CORAMATE/SPIROTOME SYSTEM
- K060467 — PRODIGY BLOOD GLUCOSE TEST SYSTEM
- K061514 — BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100
- K061751 — DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
- K051688 — FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
- K053246 — PATIENT MATCHED HIP STEM
- K053584 — IPLAN RT DOSE
- K053623 — NFIX FUSION SYSTEM
- K060191 — ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT
- K060232 — TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
- K060425 — PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
- K060643 — QL LOCKING SYRINGE
- K061044 — FEATHERLITE AQUA TOCODYNAMOMETER
- K061058 — NEOZOLINE VENTILATION TUBES
- K061363 — AGILIS NXT STEERABLE INTRODUCER
- K061365 — CHECKPOINT WITH ACCUSTIM TECHNOLOGY
- K061452 — TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
- K061593 — ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
- K061619 — INSPECTRA STO2 TISSUE OXYGENATION MONITOR
- K061682 — GE VOLUSON E8 ULTRASOUND SYSTEM
- K061698 — MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
- K061732 — TAP-T
- K061816 — GALAXY
- K061817 — LIGHTSPEED 7.1 CT SCANNER SYSTEM
- K061859 — INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
- K060497 — BABYAIR
- K060986 — HEAD BED
- K061011 — COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
- K061133 — SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S
- K061135 — MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
- K061398 — SNUG PLUG PUNCTUM PLUG
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