FDA 510(k) clearances — page 417
clearances on record, most recent first.
Clearances — page 417
41,601–41,700 of 175,770- K122522 — DENTOETCH QUICKBOND BOND ACTIVATOR
- K122940 — ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
- K123208 — DIGITAL RETINAL CAMERA
- K123330 — IOGYN ENDOSCOPE
- K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
- K123415 — BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
- K123477 — VIA MICROCATHETER, VIA PLUS MICROCATHETER
- K123589 — CADWELL DISPOSABLE PROBE HANDLE
- K123765 — GUIDEZILLA GUIDE EXTENSION CATHETER
- K130157 — AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
- K130468 — ORBIT INFUSION SET
- K122059 — ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
- K122702 — BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
- K123219 — URGOCLEAN ABSORBENT WOUND DRESSING
- K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
- K123546 — 3M ATTEST(TM) AUTO-READER
- K123628 — STERILE LATEX SURGICAL GLOVE
- K123767 — LANX FUSION SYSTEM- SA
- K123890 — ACUMED CANNULATED SCREW SYSTEM
- K121520 — ULTRASONIC NEBULIZER (MESH TYPE)
- K121593 — 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
- K122415 — X-FIX DYNAMIC EXTERNAL DISTRACTOR
- K122918 — RAYSCAN A-EXPERT
- K123070 — GALILEOS FAMILY
- K123108 — TVC IMAGING SYSTEM MODEL NIRS-MC7-70
- K123225 — BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
- K123298 — FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
- K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
- K130142 — FLIXENE IFG VASCULAR GRAFT
- K130210 — MEDELA THOPAZ
- K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
- K120014 — STA- COAG CONTROL (N+ABN) PLUS
- K121622 — NIDEK RS-3000
- K121747 — FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
- K121933 — NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
- K122534 — IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
- K122907 — FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
- K123161 — SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
- K123186 — RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
- K123557 — EASYCARE ONLINE
- K123782 — PARAGON HIP SYSTEM
- K123783 — ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
- K123929 — BEGOPAL+
- K123933 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
- K123948 — CHINA NAILS AND ACCESSORIES
- K130124 — CATALYST II AND III
- K130351 — NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
- K130435 — VERSAPORT V2 BLADELESS OPTICAL TROCAR
- K120089 — BIOGENESIS IMPLANT SYSTEM
- K121156 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
- K122412 — VISIOFOCUS
- K122602 — NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
- K123169 — ORALID
- K123370 — EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
- K123416 — INSIGNIA WITH ITERO
- K123522 — OPTIMA MR450W
- K123897 — K SERIES CPAP SYSTEMS
- K124053 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K130091 — PULMOSAL
- K130234 — NUVON VITALS CHARTING SYSTEM
- K130251 — ESOPHAGUS BOUGIE SET
- K130280 — CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
- K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
- K130359 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
- K130493 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
- K130520 — CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
- K121685 — SOPROCARE
- K121864 — PERKINELMER 226 SAMPLE COLLECTION DEVICES
- K122071 — GETINGE 400HC-E / SERIES STEAM STERILIZER
- K122113 — MEMORY METAL STAPLES, EASYCLIP
- K122634 — IODOFOAM IODOPHOR FOAM DRESSING
- K122981 — RAYSCAN A-EXPERT 3D
- K123345 — DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
- K123584 — SYNGO, CT BONE READING
- K123862 — ZIMMER NEXEL TOTAL ELBOW
- K123939 — S4 SPINAL SYSTEM
- K130153 — HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
- K113164 — DISCOVERY TMAX MANUAL WHEELCHAIR
- K121825 — CS-MAG II
- K121904 — GYNECOLOGY STERILIZATION TRAY
- K122736 — DX-D IMAGING PACKAGE
- K123073 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
- K123487 — GSO GS1 CANNULATED SCREW SYSTEM
- K123614 — SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
- K123702 — SILEX SACROILIAC JOINT FUSION SYSTEM
- K123815 — SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
- K123875 — AAP RADIUS SET 2.5
- K130113 — PICCOLO LACTATE TEST SYSTEM
- K130395 — STEREOS WORKSTATION
- K113042 — REVOIS IMPLANT SYSTEM
- K113636 — BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
- K121285 — ORAVAN OSA
- K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY
- K122306 — SYNOVIS COLLAGEN MATRIX (TBD)
- K122468 — ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
- K122469 — ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
- K122806 — IMAGE WORKS PANOURA
- K123151 — ENDOSEE MODEL 8000 U-SCOPE
- K123212 — ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
- K123228 — INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
Data sourced from openFDA. This site is unofficial and independent of the FDA.