FDA 510(k) clearances — page 551
clearances on record, most recent first.
Clearances — page 551
55,001–55,100 of 175,825- K081196 — SPINAL USA VBR SYSTEM
- K081759 — NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V
- K082051 — COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
- K082258 — CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
- K082338 — POLYBONE GRANULE & BLOCK
- K082402 — OSDX HIP BMD SYSTEM
- K082615 — GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
- K082732 — MODIFICATION TO: CAPSTONE SPINAL SYSTEM
- K082928 — STRAIGHT FIRE HOLMIUM LASER FIBER
- K082944 — CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
- K072926 — HELONTIX VENT
- K073582 — VRIICU SYSTEM
- K080632 — CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
- K080919 — NXSTAGE PUREFLOW SL
- K081626 — FLOWPICC CONSOLE
- K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
- K081710 — APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
- K082063 — PRELUDE SHORT SHEATH INTRODUCER
- K082081 — MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III
- K082092 — DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
- K082158 — DENSEO FAIRY
- K082232 — EVIS MD PLANTIUM BLUE
- K082336 — XR-EXPRESS
- K082398 — ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
- K082445 — CURATIVE980 DIODE LASER
- K082446 — BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
- K082666 — ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
- K082681 — VACORA VACUUM ASSISTED BIOPSY SYSTEM
- K082856 — CARAPASTE ORAL WOUND DRESSING
- K082890 — VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2
- K082916 — HRB-127-32 HIGH RESOLUTION BRAIN COIL
- K081793 — PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER
- K082012 — COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
- K082213 — GS III FIXTURE SYSTEM
- K082447 — DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE
- K082543 — SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
- K082684 — 4D VIEWER RADIOLOGY, MODEL USWP-100A
- K082703 — MRDH BANDAGE
- K082828 — SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
- K073368 — 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
- K073522 — VITRIFICATION KIT & VITRIFICATION WARMING KIT
- K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
- K080851 — A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
- K081107 — CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
- K081654 — HEM-9000AI
- K081717 — TRICOS A RESORBABLE BONE SUBSTITUTE
- K081832 — ENSPLINTCMX CLAVICLE PIN
- K081890 — SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
- K082017 — STARR FRAME STEINMANN PIN
- K082018 — T2 FLEXIBLE NAIL
- K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
- K082052 — MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
- K082220 — SOMATOM FLASH DS
- K082236 — CD HORIZON SPINAL SYSTEM
- K082250 — AURAGEN CORTICAL SURFACE ELECTRODES
- K082332 — NUVASIVE SPHERX SYSTEM
- K082350 — PAX-500
- K082653 — CENTERING INTRALUMINAL APPLICATOR
- K082675 — STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
- K082680 — LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
- K082702 — EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
- K082718 — TEMPUSIC PATIENT MONITOR
- K082830 — INFX-8000H, INFINIX-I
- K082959 — PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
- K080194 — VIDAS CEA (S) ASSAY
- K080275 — NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K080347 — UNISCAN -DOA SYSTEM
- K080348 — OXISCAN II DATA MANAGEMENT SYSTEM
- K080559 — DIO SM IMPLANT SYSTEM
- K081053 — PIVOT ASSIST
- K081178 — OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
- K081321 — MODIFICATION TO MIRAGE MICRO
- K081385 — URESTA PESSARY
- K081670 — THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
- K081997 — PERFADEX WITH THAM
- K082237 — PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
- K082330 — PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
- K082601 — UltraClot, UltraClot OTC
- K082802 — MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
- K081187 — BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001
- K081401 — MAYFIELD MR/X-RAY SKULL CLAMP
- K081447 — FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
- K081681 — VITRECTOMY CUTTER AND ACCESSORIES
- K081884 — MAJOR.BASE 20
- K082096 — POWERLIPO LASER SYSTEM
- K082103 — LTM WOUND DRESSING
- K082202 — HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B
- K082229 — S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
- K082242 — ICON, MODEL C3
- K082247 — EVIS MD PLATINUM RED LIGHT THERAPY
- K082280 — SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR
- K082311 — EXSUDEX WOUND DRAINAGE PUMP
- K082326 — ZONARE ULTRA ULTRASOUND SYSTEM
- K082420 — TRACHEOSCOPIC VENTILATION TUBE (TVT)
- K082486 — GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
- K082592 — LDR SPINE EASYSPINE SYSTEM
- K082657 — RTX RESPIRATOR
- K082761 — GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
- K082815 — WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
- K082816 — GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.