FDA 510(k) clearances — page 622
clearances on record, most recent first.
Clearances — page 622
62,101–62,200 of 175,825- K060030 — THE DOUBLE GLOVE
- K060848 — BOD POD
- K061043 — ZIMMER CONTOUR RESTORATIVE SYSTEM
- K061210 — FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
- K061280 — V-2200 INFANT INCUBATOR
- K061360 — NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
- K061440 — P.D
- K061527 — CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
- K061609 — GE DATEX-OHMEDA AISYS
- K061624 — VITREA, VERSION 3.9
- K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
- K061684 — MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
- K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
- K053476 — ALLWOUND
- K060939 — RANGER IRRIGATION FLUID WARMING SYSTEM
- K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
- K061161 — BLOOD PRESSURE METER, MODEL CH-311B
- K061427 — PRE-IMPRESSION CONDITIONING SOLUTION
- K061487 — DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
- K061625 — AUTOBONE2
- K052711 — EMJOI TENS DEVICE
- K052767 — AFIBALERT ATRIAL FIBRILLATION DETECTOR
- K052908 — INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
- K053195 — SPIDERX EMBOLIC PROTECTION DEVICE
- K053562 — ZIMMER COLLAGEN REPAIR PATCH
- K060243 — OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
- K060281 — VS-800 VITAL SIGNS MONITOR
- K060316 — COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
- K060483 — VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
- K060509 — PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
- K060745 — ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
- K060883 — PILOT TEST OR DETECTIVE AUDIOMETERS
- K060888 — ACELL POWDER WOUND DRESSING
- K060900 — SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
- K061034 — BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
- K061038 — BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490
- K061057 — BREAS ISLEEP 20+
- K061193 — CREATININE
- K061254 — EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
- K061301 — COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
- K061302 — DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
- K061395 — CALSET COMPOSITE HEATER
- K061443 — SMART USBLITE, MODEL M011120
- K061520 — VIPER SPINE SYSTEM
- K061563 — EBI ARRAY SPINAL SYSTEM
- K061587 — FULLCARD ANALYSIS
- K060404 — AG-PLUS, MODEL 91210
- K060439 — LUNG FLUTE
- K060702 — 4CIS VANE SPINE SYSTEM
- K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400
- K061120 — SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
- K061157 — SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
- K061317 — ILED
- K061453 — HI-TORQUE WHISPER VIEW GUIDE WIRE
- K061503 — DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
- K061605 — NEMIO XG, SAA-580A
- K060300 — CONFIDENCE HIGH VISCOSITY BONE CEMENT
- K060405 — SOYALA, SOYALA BLUE
- K060842 — REVJET TURBO
- K061024 — PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
- K061032 — DEPOTONE
- K061205 — MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR
- K061456 — A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
- K061590 — SMDIE DEVICE INTERFACING SYSTEM
- K061606 — DEFIBRILLATOR CABLE TESTER, MODEL DT2200
- K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
- K061117 — NANOLITE SKIN CARE SYSTEM
- K061169 — ENDOSSEOUS DENTAL IMPLANT
- K061324 — EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
- K061347 — VITEK 2 GRAM POSITIVE VRSA SCREEN
- K061546 — QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
- K042955 — CUTICOVER SKIN BARRIER DEVICE
- K053400 — ACUMEN SINGLE-LUMEN DELIVERY SHEATH
- K053409 — 3M LIQUID BANDAGE
- K060047 — CARTO RMT EP NAVIGATION SYSTEM V8
- K060431 — ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
- K060456 — MEDLINE COLLAGEN WOUND DRESSING
- K060508 — POINTER PLUS
- K060510 — DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
- K060517 — POINTER EXCEL
- K060825 — MULTI-USE ELECTRONIC PREGNANCY TEST
- K060945 — PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
- K061041 — US SPINE FACET FIXATION SYSTEM
- K061203 — ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
- K061206 — ACUTE BONE SCREW
- K061281 — INSIGHT HEAD COIL
- K051965 — OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM
- K052818 — EZ SMART-168 GLUCOSE MONITORING SYSTEM
- K060143 — LNCS AND SPO2.COM SENSORS
- K060500 — SPEEDY ORTHODONTIC SCREW
- K060501 — IMPLANTIUM II
- K060819 — COOL.CLICK 2
- K061409 — SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
- K053037 — ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
- K053381 — WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
- K053422 — RAPIDONE-COCAINE-150 TEST
- K060192 — APEX KNEE SYSTEM
- K060237 — CMB ANTIMICROBIAL DRESSING
- K060364 — VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
- K060524 — DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.