FDA 510(k) clearances — page 437
clearances on record, most recent first.
Clearances — page 437
43,601–43,700 of 175,770- K113546 — ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
- K120566 — O2PAK OXYGEN GENERATOR
- K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREEN
- K121376 — COMPRESSION CARE FLIGHT
- K121759 — CONE-TROL LIQUID CHEMISTRY CONTROLS
- K121912 — E1 EAR SENSORS
- K121229 — INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
- K121788 — NIO 5MP
- K121907 — DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
- K112389 — SURGICASE CONNECT, SURGICASE GUIDE
- K113162 — SLIDEWIRETM(TRADEMARK PENDING)
- K113229 — VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
- K113498 — DISPOSABLE TORQUE DEVICE
- K120569 — GEMORE TENS SYSTEM
- K120839 — NOVACATH SECURE IV CATHETER SYSTEM-18G
- K120849 — HYBRID ARCTICGEL PAD
- K121159 — INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
- K121416 — GMK SPHERE
- K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
- K121517 — VERSAVUE ENTERPRISE SUITE
- K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
- K121658 — ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
- K121808 — CASIAN, 3.5/4.5 CONNECTORS
- K121835 — DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE
- K121948 — CR 10-X DIGITIZER
- K122010 — Z6 DIAGNOSTIC ULTRASOUND SYSTEM
- K111401 — BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
- K111406 — BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
- K112368 — CAPNOSTREAM20P WITH AI/ODI
- K112622 — HANDHELD ECG MONITOR
- K113382 — ACE ALT REAGENT
- K113754 — CFR QUANT
- K120211 — SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
- K120598 — PROCARE MONITOR B40
- K120834 — CORPATH 200 SYSTEM
- K120865 — RSCRIBE ELECTROCARDIOGRAPH
- K120970 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
- K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
- K121572 — CONTINUOUS SINGLE CULTURE COMPLETE
- K121868 — MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
- K120325 — CONNECTED CARE MOBILE APPLICATION
- K120366 — INTELLIVUE PATIENT MONITOR
- K120640 — INSUFLOW SYNERGY PORT
- K120824 — 3.9MM REELX STT SUTURE ANCHOR SYSTEM
- K121115 — M.U.S.T PEDICLE SCREW SYSTEM
- K121162 — POLARIS Q-SWITCH RUBY SYSTEM
- K121319 — ZIO PATCH
- K121323 — MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
- K121349 — IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
- K121355 — WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K121417 — XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
- K121638 — ST80I STRESS TEST SYSTEM
- K121671 — PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
- K121777 — U2 ACETABULAR CUP, PLASMA SPRAY
- K111353 — ACCU-CHECK COMBO SYSTEM
- K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
- K113311 — TIO2MESH TM
- K120562 — PERFORMAX PEDIATRIC EE TOTAL FACE MASK
- K121253 — MERIDIAN CRANIAL PERFORATOR
- K121428 — NON-CONTACT CLINICAL THERMOMETER
- K121531 — A&J 5L POCA SERIES OXYGEN CONCENTRATOR
- K121832 — RESOLVE BILIARY LOCKING DRAINAGE CATHETER
- K121954 — NMI MICROCATHETER
- K113306 — CARDIO 7
- K113335 — HEARTRAIL III GUIDING CATHETER
- K113446 — VIGNET TELEHEALTH MANAGER
- K113562 — 3MP COLOR LCD MONITOR, RADIFORCE RX340
- K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
- K120564 — CALYPSO SYSTEM
- K120920 — HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
- K121160 — MAGNETOM SPECTRA
- K121474 — DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
- K121600 — ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
- K121833 — OSTOMY IRRIGATION SET
- K121837 — NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
- K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
- K112390 — MONICA AN24
- K112413 — RI MSC (MIGRATION SEDIMENTATION CHAMBER)
- K112840 — CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
- K113192 — HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
- K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
- K113513 — PLANCET
- K113574 — FLEXITIME MONOPHASE PRO SCAN
- K120402 — CRUX VENA CAVA FILTER SYSTEM
- K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
- K120481 — LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
- K120827 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
- K120903 — CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
- K121017 — CAPNOGRAPHY PAD (92516)
- K121161 — EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
- K121170 — RESIN 11
- K121733 — INFILL INTERVERTEBRAL BODY FUSION DEVICE
- K121745 — MANTARAY GUIDEWIRES
- K121767 — CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
- K110558 — CS1000 LIGHT THERAPY DEVICE
- K112193 — ARROW REVERSE SHOULDER SYSTEM
- K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT
- K113620 — MYRIAN 1.11
- K120812 — RENAISSANCE
- K120836 — 0.9% SODIUM CHLORIDE FLISH SYRINGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.