FDA 510(k) clearances — page 477
clearances on record, most recent first.
Clearances — page 477
47,601–47,700 of 176,542- K111006 — CI-SNAP WOUND CARE SYSTEM
- K111280 — V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
- K111362 — REXIOUS SPINAL FIXATION SYSTEM
- K111536 — METASURG DIGIFUSE IMPLANT
- K111552 — ELECSYS T3 CALCHECK 5
- K111750 — EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
- K111801 — SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
- K093548 — AVIE A1C TEST SYSTEM
- K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA)
- K102401 — HEMI IMPLANT; MINI HEMI IMPLANT
- K103745 — BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
- K110213 — GE DATEX-OHMEDA AISYS
- K110227 — OPTIMA CT660
- K110608 — SEVOFLURANE VAPORIZER ADAPTOR
- K110797 — COMMUNIFY PACS VIEWER
- K110867 — STERI-DENT, STERI-SURE
- K110922 — PATIENT MONITOR
- K111061 — REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
- K111205 — MICROSCAN (R) MICROSTREP PLUS (R) PANELS
- K111291 — AIDITE ZIRCONIA DENTAL CERAMICS
- K111299 — AXXENT RADIATION SHIELD - RIGID
- K111316 — AAP CANNULATED SCREWS
- K111399 — SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
- K111598 — POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
- K111774 — PATHWAY MODEL 07XXXX
- K101181 — BEL-CAT
- K101407 — ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
- K103129 — ENTROPY EASYFIT SENSOR
- K103676 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
- K110443 — BD INSYTE AUTOGUARD BC
- K110556 — MINI TELEMETRY SYSTEM
- K110852 — DOLPHIN 3 FLUID MANAGEMENT SYSTEM
- K111147 — MEDLINE VESSEL CANNULA
- K111304 — OPTIMA XR120
- K111380 — NEURON MAX SYSTEM
- K111469 — STAXXSD SYSTEM
- K111495 — COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
- K111725 — MOBILEDIAGNOST WDR
- K111835 — PLATEAU SPACER SYSTEM
- K111897 — ABL90
- K103731 — CAPSTONE R SPINAL SYSTEM
- K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT
- K110439 — DOMAIN SURGICAL SYSTEM
- K110956 — MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
- K111002 — REPROCESSED ENDOSCOPIC TROCARS
- K111144 — CANDELA GENTLELASE FAMILY OF LASERS
- K093755 — AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K102643 — SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
- K103685 — PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
- K110197 — EXACTECH GIBRALT SPINAL SYSTEM
- K110298 — OPIATE ENZYME IMMUNOASSAY
- K110328 — ACG-8511 PORTABLE ECG MONITOR
- K110847 — SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
- K110857 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
- K110928 — BODY ANALYSIS SCALE, MODEL BG 17
- K111045 — CENTRO FAMILY OF MANUAL WHEELCHAIRS
- K111328 — POWDER FREE NITRILE EXAMINATION GLOVES
- K111416 — FALCON
- K111417 — THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K111560 — WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
- K111706 — VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
- K111803 — G-SCAN
- K111864 — E-CUBE 9
- K094048 — PERCUPRO MESSENGER BALLOON CATHETER
- K110285 — NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
- K110577 — OSSEOFUSE DENTAL IMPLANT SYSTEM
- K110697 — TIGER SYRINGES AND NEEDLES
- K110869 — CARA
- K110960 — ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
- K111034 — AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K111065 — STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
- K111240 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
- K111856 — SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
- K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
- K103077 — ECG PEN
- K110418 — POWDER FREE NITRILE EXAMINATION GLOVES
- K110507 — CARDIAC SCANNER AND PROCESSING SYSTEM
- K110842 — ATLAS SPINE PEDICLE SCREW SYSTEM
- K111062 — APEX KNEE SYSTEM, APEX ALL POLY TIBIA
- K111231 — PANOURA 18S
- K111312 — SANTEVIEW
- K111652 — MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
- K111850 — VACCESS PTA DILATATION CATHETER
- K094026 — STERI-DENT, STERI-SURE
- K101997 — ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
- K110538 — PRO FIXATION SYSTEM
- K110670 — VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
- K110884 — EASYFIT SILKGEL NASAL MASK
- K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
- K111076 — SOLANAS AVALON POSTERIOR FIXATION SYSTEM
- K111077 — ORTHOSORB RESORBABLE PINS
- K111397 — TITAN TI SUTURE ANCHOR SYSTEM
- K111747 — ENDOLOGIX AFX INTRODUCER SYSTEM
- K101194 — NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
- K110824 — ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT
- K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K111031 — PAINFUSOR CATHETER
- K111150 — STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
- K111435 — DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K111506 — ELECSYS PRECICONTROL VARIA 3
Data sourced from openFDA. This site is unofficial and independent of the FDA.