FDA 510(k) clearances — page 587
clearances on record, most recent first.
Clearances — page 587
58,601–58,700 of 176,637- K072778 — BRIO ACUPUNCTURE NEEDLES
- K072818 — PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
- K073180 — SMARTSPONGE PLUS SYSTEM
- K070690 — THE LIFE VESSEL
- K071127 — FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
- K071161 — ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K071921 — INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
- K072048 — LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE
- K072470 — BIOELAST 5-0 SUTURE, MODEL 500100
- K072483 — ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
- K072522 — THERMOFORM SHEET MATERIALS AND ACCESSORIES
- K072604 — DUO TEMP
- K072643 — CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
- K072695 — VITEK 2 GRAM POSITIVE TIGECYCLINE
- K072698 — CONFIDANT 2.5
- K072755 — GALEMED CPAP MASK
- K072873 — LBS-63-16 BREAST ARRAY COIL
- K072874 — LBS-127-16 BREAST ARRAY COIL
- K072912 — SOPRO 225 DUAL HALOGEN LIGHT SOURCE
- K072946 — HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
- K072952 — GE ECHOPAC
- K073032 — PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
- K073104 — SKINTACT AND VARIOUS OTHER TRADENAMES
- K073124 — COLLIMARE COLLIMATOR FAMILY
- K073133 — INTERSTITIAL NEEDLES
- K073134 — A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
- K073165 — DRAD-3000E, RADREX-I
- K070375 — EARLYSENSE ES-16 SYSTEM
- K070968 — CHOY COMPRESSION FRAME
- K071657 — TRU FLU
- K072092 — XPOD/XMAP NERVE STIMULATOR
- K072306 — BIOXTRA MOISTURIZING GEL
- K072593 — A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
- K072659 — RAD VISION, MODELS E AND EU
- K072747 — UNIDUS MAGNUM MALE LATEX CONDOM
- K072933 — SPI CONTACT PLATFORM O 4.0 MM
- K073053 — COLPO-MASTER
- K063733 — RESOLVE BILIARY DRAINAGE CATHETER
- K071895 — VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR
- K072371 — ODYSSEY WORKSTATION
- K072549 — TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
- K072554 — ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
- K072769 — ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
- K072984 — SATURN 9000-550
- K071224 — DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
- K072033 — OTODYNAMICS OTOPORT
- K072786 — ACUSON S2000 ULTRASOUND SYSTEM
- K072983 — SATURN 9000-750
- K073056 — DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
- K062607 — POLYGRAFT BGS
- K063852 — ACCESSA CHOLESTEROL PANEL
- K070935 — T.B.R. ZIRCONNECT
- K071059 — DEPUY SPA POROUS COATED PROXIMAL SLEEVE
- K071413 — HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
- K071619 — SPY FLUORESCENT IMAGING SYSTEM
- K071724 — LUCENT
- K071760 — MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
- K071802 — TESLA GUARD, MODEL EFT G04
- K071813 — MASTERGRAFT PUTTY
- K071826 — THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
- K071890 — ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
- K071918 — CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
- K072156 — OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER
- K072216 — KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
- K072241 — PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
- K072248 — VIAPEEL PEELABLE INTRODUCER
- K072250 — SUPERCABLE GRIP AND PLATE SYSTEM
- K072378 — PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
- K072419 — ADVANTIV SAFETY I.V. CATHETER
- K072479 — FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
- K072724 — CXI SUPPORT CATHETER
- K072748 — MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
- K072808 — SPEEDICATH COMPACT
- K072916 — TRILOGY SYSTEM WITH RAPIDARC
- K073016 — TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
- K073025 — VASCUTRAK II PTA DILATATION CATHETER
- K062264 — COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
- K070569 — SM INTERNAL./EXTERNAL IMPLANT SYSTEM
- K071957 — PINNACLE PELVIC FLOOR REPAIR KITS
- K072014 — VITASCORE
- K072240 — GUNTHER TULIP VENA CAVA FILTER
- K072245 — EMULATE ADVANCED
- K072247 — STERICAN HYPODERMIC NEEDLES
- K072359 — AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
- K072586 — CONFORMIS UNI-CONDYLAR KNEE SYSTEM
- K072710 — NEXFIX COMPRESSION PIN
- K072960 — CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
- K071151 — TENSION BAND ANTERIOR SPINAL SYSTEM
- K071165 — ISCALERT SENSOR SYSTEM
- K071711 — ASCA-CHEK
- K072135 — KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
- K072423 — 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
- K072644 — UNICRYL QUICK
- K072645 — UNIGLACTIN
- K072646 — UNICAPRONE
- K072956 — MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
- K073010 — ROYALE AE 9036 LSP INJECTOR
- K070550 — AUSCO ES-3100
- K071365 — AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
- K071388 — GENTIAN CYSTATIN C IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.