FDA 510(k) clearances — page 655
clearances on record, most recent first.
Clearances — page 655
65,401–65,500 of 175,825- K050072 — GOODKNIGHT 425ST
- K050459 — ATRICURE ISOLATOR TRANSPOLAR PEN
- K050649 — SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
- K050662 — QUANTA LITE SP100 ELISA
- K050673 — CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
- K050727 — MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
- K050733 — OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
- K050964 — PV 1900 SYNCHRO 0.016 GUIDEWIRE
- K051084 — DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
- K051265 — ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K051307 — SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
- K051321 — INVIEW
- K051402 — ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
- K033720 — ARI COLD SPRAY
- K050871 — RIVA PROTECT
- K051190 — XENFORM SOFT TISSUE REPAIR MATRIX
- K051225 — EKOS MICRO-INFUSION SYSTEM
- K051228 — BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
- K051303 — BIO-CONSOLE, MODEL 560
- K051387 — LEVO COMFORT II
- K042164 — SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
- K042415 — MENDEC SPINE
- K050114 — SUPERCATH Z3V
- K050397 — VELASMOOTH, SHAPER
- K050603 — OLPUR DIALYZER, MODEL HD 190
- K050767 — STERLING INTERFERENCE SCREW ST
- K051105 — BASIS VERTEBRAL BODY SPACER
- K051218 — MODIFICATION TO: UNICAP SPECIFIC IGE
- K051250 — AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
- K043408 — PIEZOSURGERY DEVICE
- K043480 — ENHANCE CLITORAL STIMULATION AID
- K050273 — FRESENIUS ART HEMOADSORPTION SYSTEM
- K050406 — NOBELSPEEDY IMPLANTS
- K050878 — ON CALL MULTI-DRUG HOME TEST CUP
- K050916 — SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
- K051029 — STELTHSTATION WIRELESS SURGEON MOUSE
- K051125 — IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
- K051179 — EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
- K051187 — REXEED SERIES DIALYZERS
- K051189 — PREVAIL DENTAL IMPLANTS
- K051235 — ON TRAK TESTCARD
- K051351 — PRECEDENCE SPECT/CT IMAGING SYSTEM
- K051470 — REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
- K031196 — SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
- K050277 — CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
- K050371 — MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
- K050486 — PROTECT TOOTH DESENSITIZER
- K050538 — IMC DRAPES
- K050915 — SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
- K051006 — IBOND NEXT GENERATION
- K051103 — HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
- K051166 — POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET
- K051347 — KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
- K043296 — COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
- K043306 — SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
- K043358 — REPROCESSED ULTRASONIC SCALPELS
- K043558 — XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A
- K050082 — CENTERPIECE PLATE FIXATION SYSTEM
- K050243 — IMMEDIA PROTHROMBIN TIME SYSTEM
- K050713 — DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
- K050776 — AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K050790 — SPOTCHEM II LDH TEST
- K050918 — KOO AMERICAS VALVE PEEP, MODEL KM-809
- K051043 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K051074 — MAS IMMUNOSUPPRESSANT CONTROLS
- K051094 — NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE
- K033591 — REPROCESSED TROCARS
- K041096 — WAGNER STERISET STERILIZATION CONTAINER
- K041511 — TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
- K041514 — TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
- K043050 — HEMCON BANDAGE AND HEMCON BANDAGE OTC
- K043574 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
- K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
- K050599 — TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
- K050734 — COOL.CLICK
- K050795 — IMBIBE BONE MARROW ASPIRATION NEEDLE
- K050870 — RIVA LIGHT CURE
- K050885 — OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
- K051123 — CALLOS IMPACT AND INJECT BONE VOID FILLER
- K051127 — KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0
- K051138 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML
- K051152 — POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
- K051304 — ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM
- K051334 — TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
- K041510 — TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
- K041512 — NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
- K043340 — EZ SMART
- K050438 — STEALTHSTATION SYSTEM UPDATE
- K050738 — FT FIBER OPTIC DELIVERY SYSTEMS
- K051036 — HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
- K040290 — DIASORIN LIAISON CMV IGM/IGG
- K040871 — FACEMASTER FACIAL TONING SYSTEM
- K041897 — MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
- K042297 — ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
- K042644 — AESKULISA TTG A AND AESKULISA TTG G
- K043377 — ZENO
- K050568 — ORLUS MINI SCREW
- K050721 — ABX ERYTROL
- K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.