FDA 510(k) clearances — page 514
clearances on record, most recent first.
Clearances — page 514
51,301–51,400 of 175,825- 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
- K093072 — STARCARE HANDPIECE MAINTENANCE UNIT
- K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
- K093035 — FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
- K093250 — PROTON THERAPY MULTILEAF COLLIMATOR
- K093393 — LIFEDOP MODEL 300ABI
- K093551 — PARADIS VASO SHIELD
- K090534 — VENOUS HARDSHELL CARDIOTOMY RESERVIORS
- K090555 — PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
- K090690 — VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
- K090819 — ONTEX TAMPON (UNSCENTED)
- K090820 — TRIA HAIR REMOVAL LASER SYSTEM
- K090832 — RAPID-I
- K091265 — ZOLL E SERIES WITH CPRREADYCHARGE
- K091426 — CERVICORE CORPECTOMY CAGE
- K091579 — FORESEE HOME
- K091644 — SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
- K091729 — ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
Data sourced from openFDA. This site is unofficial and independent of the FDA.