FDA 510(k) clearances — page 521
clearances on record, most recent first.
Clearances — page 521
52,001–52,100 of 176,542- K083811 — W&H HANDPIECE ANESTO, MODEL: RA-5
- K090271 — HYDROCOAT MESH
- K091867 — ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
- K092047 — ASCENSION METAL GREAT TOE SYSTEM
- K092158 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE
- K092831 — DISPOSABLE HYPODERMIC NEEDLE
- K092893 — TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
- K092933 — SAF (SELF ADJUSTING FILE)
- K093231 — ALBOGRAFT VASCULAR PROSTHESIS
- K093308 — MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
- K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
- K093519 — MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET
- K093658 — RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS
- K093659 — ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
- K093730 — PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
- K092118 — ANGIOGRAPHIC CATHETER, MODEL ANGIOS
- K092583 — SOPROLIFE
- K092811 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903
- K092890 — ASTHMA MONITOR AM3
- K092942 — VITAL SLEEP
- K093825 — AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
- K093832 — LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
- K093866 — EVALVE STEERABLE GUIDE CATHETER
- K092739 — MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
- K092864 — AESPIRE 7900, AESPIRE VIEW
- K093596 — LUMOS, MODEL R 72B
- K093925 — LIFENET SYSTEM
- K092479 — SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
- K092909 — SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
- K093360 — OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
- K093588 — EXPLORER 4D TREATMENT PLANNING SYSTEM
- K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
- K090025 — MATRIX RF APPLICATOR
- K090401 — ORTHOSS
- K090467 — DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
- K091506 — DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
- K091954 — MICRO-STICK SET
- K092330 — OC-SENSOR DIANA IFOB TEST
- K092652 — FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
- K092827 — DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
- K093008 — HALO ABLATION CATHETER, MODEL 90-9100
- K093013 — BLOOD PRESSURE MONITOR, MODEL MD200A
- K093355 — PCR ELEVA 1.2
- K093469 — CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
- K093807 — HARDYDISK AST TELAVANCIN,30UG
- K093982 — XELERIS 3 PROCESSING AND REVIEW WORKSTATION
- K090345 — MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL
- K090637 — CARDIO-WRAP
- K091182 — CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000
- K091994 — MOUNTAINEER LAMINOPLASTY SYSTEM
- K092346 — SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
- K092447 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
- K092636 — POGS, MODEL 65/130
- K092780 — INF 4160 PLUS, MODEL D-FJ31F
- K092833 — ENDOMAX CORDLESS ENDODONTIC HANDPIECE
- K092900 — EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
- K093349 — MEDLINE CURAD WOUND DRESSINGS
- K093502 — VARI-LASE ENDOVENOUS LASER CONSOLE
- K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM
- K093809 — VIDAR DENTAL FILM DIGITIZER
- K093817 — GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
- K090341 — MICHIGAN CRANIAL RESHAPING ORTHOSIS
- K092162 — 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
- K092772 — PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
- K092923 — CYTORI PUREGRAFT 250/PURE SYSTEM
- K092925 — 3D ASL
- K093503 — INTRAX FILM PROCESSOR
- K083384 — THERMODILUTION CATHETER
- K090312 — TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
- K091339 — BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
- K092555 — UNO NARROW IMPLANT
- K093111 — MIKRO-CATH, MODEL 825-0101
- K093465 — FUSION SYSTEM
- K093520 — VIVOSIGHT TOPICAL OCT SYSTEM
- K082586 — LIGHTWAVE PROFESSIONAL DELUXE
- K091557 — LUNG FLUTE THERAPEUTIC
- K092172 — EXEL I.V. EXTENSION SET
- K082249 — MORPHEUS
- K091541 — MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES
- K093392 — MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
- K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
- K090986 — STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
- K092087 — MEDTRONIC DENTAL TCP
- K092174 — ENABLER-P CATHETER SYSTEM, MODEL 3000
- K092791 — KNEEHAB XP CONTROLLER, MODEL 411
- K092906 — VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
- K093006 — FONIX ,MODEL 8000
- K093139 — BANTAM,48XXXXXX, 50XXXXXX
- K091227 — PIEZOSURGERY 3; OSSTEM PIEZO
- K091585 — VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
- K092588 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918
- K092855 — MILTEX MEMBRANE TACK KIT
- K092929 — SYNTHES MATRIX SYSTEM
- K093067 — LIPOSE DISPOSABLE CANNULA
- K093141 — MARS HOLTER ANALYSIS WORKSTATION
- K091851 — STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS
- K092674 — SIMPLER TOADSTOOL MINI IMPLANT
- K093037 — PENTEX EC-3890LI
Data sourced from openFDA. This site is unofficial and independent of the FDA.