FDA 510(k) clearances — page 390
clearances on record, most recent first.
Clearances — page 390
38,901–39,000 of 176,542- K132857 — RESPIRATORY GAS HUMIDIFIER
- K133290 — COLLACARE DENTAL
- K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
- K133514 — XCAGE INTERBODY FUSION SYSTEM
- K133672 — REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
- K140185 — OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
- K140216 — ORTHOPEDIC FIXATION SYSTEMS
- K140818 — IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
- K130065 — BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
- K132178 — MOSTDI DENTAL IMPLANT SYSTEM
- K132617 — MEDTRONIC INPUT PS INTRODUCER
- K133149 — BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
- K133516 — CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
- K133573 — FIAGON NAVIGATION SYSTEM
- K133590 — SOMATOM PERSPECTIVE
- K133600 — COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
- K133882 — CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
- K140959 — ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
- K131917 — NEURODYN COMPACT, NEURODYN II
- K132570 — ELECTRIC HANDPIECE SYSTEM
- K132755 — NEUROMATE FRAMELESS GEN II
- K133387 — ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED
- K133862 — ACCU-CHEK AVIVA PLUS SYSTEM
- K133879 — FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
- K140125 — NEW STETIC DENTAL AMALGAM ALLOY
- K140146 — COMFORTSOFT SOFT DENTURE LINER SYSTEM
- K140229 — GENERAL SPINAL SYSTEM
- K140368 — FAMILY OF DISPOSABLE LENSES
- K130889 — SPLIT CATH RG
- K132042 — AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
- K132179 — ARASYS
- K132184 — ACESSA GUIDANCE HANDPIECE
- K133271 — OPTEO, VIDEOGRAPH HD
- K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
- K133542 — PURACYN PLUS SKIN AND WOUND
- K133580 — ARTIS ONE
- K133652 — GSP NEONATAL TOTAL GALACTOSE KIT
- K133653 — ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
- K133821 — EMPRINT ABLATION SYSTEM
- K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM
- K140031 — SUCTION PUMP
- K140501 — XENMATRIX SURGICAL GRAFT
- K140517 — SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
- K140733 — CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
- K140839 — CAIMAN SEAL AND CUT TECHNOLOGY
- K123607 — OCTANE ELEVATE SPINAL IMPLANT SYSTEM
- K131946 — ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
- K132933 — THE MOSES ELITE APPLIANCE
- K133237 — GEL-BEAD EMBOLIZATION SPHERES
- K133588 — FORA CARE BLOOD PRESSURE MONITORING SYSTEM
- K133951 — SMARTTOUCH
- K134023 — 2300 SERIES MGO PORTABLE OXYGEN
- K134045 — ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM
- K140179 — EASY GO VAC
- K140247 — MTA FILLAPEX
- K140617 — PINIT SMALL BONE FUSION SYSTEM
- K140677 — MYLABSSOGNO
- K140742 — RELIANCE ANTERIOR CERVICAL PLATE
- K140749 — INFINITY TOTAL ANKLE SYSTEM
- K140764 — LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
- K140771 — PHILIPS ELEVA WORKSPOT
- K140834 — TERASON USMART3400 ULTRASOUND SYSTEM
- K140851 — INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K140857 — INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K130557 — NEURAGEN 3D
- K131525 — SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K131838 — DIODE LASER FOR HIAR REMOVAL
- K131956 — QUICK RELAX PRO
- K132433 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
- K132563 — PINOOK STIMULATOR
- K132882 — ELECTRIC BREAST PUMP
- K132993 — COUNTER OTC TENS DEVICE
- K133007 — DX3000-L
- K133278 — DISCOVERY IGS 740
- K133870 — FLUID LEVEL MONITOR
- K134013 — LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
- K140080 — ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
- K140123 — POLARIS SPINAL SYSTEM -TRANSLATION SCREW
- K140763 — MONOFILAMENT POLYPECTOMY SNARE
- K131889 — EUM 100PRO
- K132077 — PATIENT MONITOR
- K132549 — ACCUTIP COVER
- K132595 — ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
- K133009 — NASAL MASK, NASAL MASK, FULL FACE MASK
- K133742 — XQ-1 INCUBATOR
- K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT
- K133897 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
- K140010 — FORTRESS PEDICLE SCREW SYSTEM
- K140445 — DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
- K140561 — AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
- K132390 — INSTINCT; PLAIN, DOTTED, ULTRA THIN
- K133649 — HEPATIC VCAR
- K133761 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
- K133829 — AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
- K140147 — BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
- K140442 — MEDSOURCE SELECTABLE IV SET
- K140560 — ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
- K140303 — ALAMO T
- K140307 — ENVOY GUIDING CATHETER
- K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
Data sourced from openFDA. This site is unofficial and independent of the FDA.